A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.

Study CR9108963: A 12-month, Randomized, Double-blind, Parallel-group, Placebo and Active-controlled Dose-range Finding Study of the Efficacy and Safety of SB-751689 in Post-menopausal Women With Osteoporosis

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00471237

Enrollment

564

Registered

2007-05-09

Start date

2007-05-14

Completion date

2008-12-26

Last updated

2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

bone mineral density,, Ronacaleret, teriparatide, alendronate,, Post-menopausal women,, osteoporosis,, SB-751689

Brief summary

This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.

Interventions

DRUGRonacaleret

100mg, 200mg, 300mg, 400mg

DRUGTeriparatide

PTH (1-34)

DRUGAlendronate

Bisphosphonate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

Inclusion: * Informed consent: Subject is willing and able to provide written informed consent. * Menopausal status: Ambulatory female aged \< 80 years at screening and \>5 years postmenopausal. * T-Score: A subject with either no or only one prevalent vertebral fracture is eligible for inclusion if she satisfies one of the following T-score requirements: If no prevalent vertebral fracture subject must have an absolute BMD value consistent with a T-score of less than or equal to -2.5 and greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine, or If one prevalent vertebral fracture subject must have an absolute BMD value consistent with a T-score of less than or equal to -2.0 and greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine. * Suitable vertebra: Two or more vertebra in the range of L1 to L4 that are suitable for BMD measurement by DXA. * Protocol compliance: Subject who, in the opinion of the investigator, is willing and able to comply with the requirements of the protocol. Exclusion: * T-Score: Has an absolute BMD value consistent with a T-score less than or equal to -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine. * Vertebral fractures: Has \>1 prevalent vertebral fracture at the screening visit. * Non-vertebral fractures: Any previous non-vertebral osteoporosis related/fragility fracture after age 40. * Spine deformity: Significant spine deformity which would preclude DXA/QCT assessments. * BMI: BMI ≥33kg/m2. * Bone metabolic diseases: Other than osteoporosis, history or concurrent diseases affecting bone metabolism (e.g., osteomalacia, hyperparathyroidism, hyperthyroidism). * GI disease: History of major upper gastrointestinal disease * Malabsorption: Active or history of malabsorption (e.g., history of celiac disease, irritable bowel syndrome or inflammatory bowel disease). * Liver disease: Past or current history of liver disease or known hepatic or biliary abnormalities, (with the exception of previously documented diagnosis of Gilbert's syndrome). * Rheumatoid arthritis: Active disease or history of rheumatoid arthritis. * Nephrolithiasis: History of or active nephrolithiasis (kidney stones). * Osteosarcoma risk: Subjects at increased risk of osteosarcoma such as those with Paget's disease of bone or any prior external beam or implant radiation therapy involving the skeleton. * Malignancy: Malignant disease diagnosed within the previous 5 years (except resected basal cell cancer). * Biological abnormalities: Any clinically relevant biological abnormality found and/or volunteered at screening (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study. * Surgical and medical conditions: Presence of the following conditions within six months prior to screening: myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, cardiac arrhythmia, clinically evident congestive heart failure, or cerebrovascular accident. * Glomerular filtration rate: Glomerular filtration rate (GFR) \<35 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation as follows: GFR (mL/min/1.73 m2) = 186 x (Serum creatinine mg/dL)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African American) (conventional units). * QT/QTc prolongation: A marked baseline prolongation of QT/QTc interval (e.g., QTc interval ≥450 msec on the Screening ECG). * Torsades de Pointes: A history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). * Liver chemistries: Liver chemistries \[aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin\] exceeding 2-fold the upper limit of the laboratory-specified reference range, at screening. * Abnormal serum calcium: Serum calcium (total or albumin-adjusted) outside the central laboratory reference range at the screening visit. * Abnormal PTH: PTH (intact or whole) outside the normal range. * Abnormal creatine phosphokinase: Creatine phosphokinase (CPK) outside the normal range. * Abnormal alkaline phosphatase: Alkaline phosphatase outside of the normal range. * Thyroid hormone replacement: Subjects receiving thyroid hormone replacement therapy must have a TSH level checked. Subjects will be excluded if TSH levels are \<0.1 or \>10.0mIU/L. However, subjects will not be excluded if TSH is in the range 0.1-4.5 mIU/L. If TSH is \>4.5 and ≤10.0mIU/mL, measure T4 and exclude the subject only if the T4 is outside the normal range. * Vitamin D deficiency: Vitamin D deficiency (serum 25-hydroxy vitamin D \< 20ng/mL, equivalent to 50nmol/L) at screening. Subjects can undergo vitamin D repletion as per local practice and be re-screened once only for vitamin D levels within the 6-week screening period. They will remain excluded if the re-screened value is \< 20ng/mL. * Previous strontium or IV bisphosphonate: Any previous treatment with strontium ranelate or intravenous bisphosphonate. * Oral bisphosphonates: Any previous treatment with an oral bisphosphonate as follows: any treatment within the last six months * one month cumulative treatment within the last 12 months * three months cumulative treatment within the past two years, or * two years cumulative treatment within the past five years. * Fluoride: Treatment with fluoride (dose greater than 10mg/day) within the previous 5 years for osteoporosis. * Digoxin: Current therapy with digoxin. * Bone metabolism drugs: Treatment with other drugs affecting bone metabolism within the last six months prior to screening: Chronic systemic corticosteroid \[e.g., glucocorticoid, mineralocorticoid\] treatment of no more than 2 intra-articular injections within the past year or use of oral, parenteral, or long-term, high-dose inhaled corticosteroids. Treatment with any topical corticosteroid will not exclude the subject from participating. Hormones \[e.g., estrogens/natural estrogen preparations(except for nonsystemic vaginal treatment), 19-norprogestins, SERMs such as raloxifene, anabolic steroids/androgens such as dehydroepiandrosterone (DHEA) or its sulfated form (DHEAS), nandrolone, tibolone, active vitamin D analogs/metabolites such as 1,25-dihydroxy vitamin D (calcitriol) or 1alpha-hydroxyvitamin D3 (1-alpha hydroxycholecalciferol), calcitonin\]. Calcineurin inhibitors \[e.g., cyclosporine, tacrolimus\] or methotrexate. * Previous anabolic agents: Treatment with PTH, PTH analogues or similar anabolic agent for osteoporosis within the last two years. * Contraindications: Contraindications to therapy with calcium or vitamin D. * Pregnancy: Women who are pregnant are not allowed in this study. * Interfering medications: Vitamin A in excess of 10,000 IU per day, heparin, or lithium, or anticonvulsant medications except benzodiazepines. * Investigational drug exposure: Administration of any investigational drug within 90 days preceding the first dose of the study drug. * Substance abuse: History or current evidence of drug or alcohol abuse within the previous 12 months. * Problems swallowing: Inability to swallow a tablet whole. The following

Exclusion criteria

do not apply to subjects allocated to the open-label teriparatide group: * Calcium channel blockers: Current therapy with calcium channel blockers diltiazem and verapamil. * Oral Azole Antifungals: Current therapy with any oral azole antifungal. * Immunosuppressants: Current therapy with cyclosporine or oral tacrolimus. * Ritonavir: Current therapy with ritonavir. * Quinidine: Current therapy with quinidine. * Macrolide Antibiotics: Subjects anticipated to require chronic use of macrolide antibiotics. * Alendronate Contraindications: Contraindications to therapy with alendronate. Additional

Design outcomes

Primary

Measure	Time frame	Description
Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)	Baseline (Day 0) and 12 Months	DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported.
Number of Participants With Hypercalcemia	Up to Month 12	Participants with albumin-adjusted serum calcium pre-dose values of \>11.0 mg/ deciliter (dL) or post-dose values of \>12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported.
Number of Participants Withdrew Due to Hypercalcemia	Up to Month 12	A confirmed albumin-adjusted serum calcium pre-dose value of \>11.0 mg/dL or post-dose value of \>12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported.
Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Up to Month 12	The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported.
Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Up to 12 Months	The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (\> 30 millimeter of mercury \[mmHg\] decrease from Baseline, \> 30 mmHg increase from Baseline), diastolic blood pressure (\> 20 mmHg decrease from Baseline and \> 20 mmHg increase from Baseline) and heart rate (\<45 and \>120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event	Up to 12 months	Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett's correction) interval, QTcF (Fridericia's correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study.
Mean Change From Baseline in Height	Baseline (Day 0), Month 6, 12 and early withdrawal	Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported.
Mean Change From Baseline in Weight	Baseline (Day 0), Month 6, 12 and early withdrawal	Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported.

Secondary

Measure	Time frame	Description
Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline (Day 0), Week 4, Month 3, 6, and 12	Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of P1NP.
Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline (Day 0), Week 4, Month 3, 6, and 12	Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of BALP.
Blood Concentrations of Ronacaleret	Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12	Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Blood concentrations of ronacaleret were reported.
Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)	Baseline (Day 0) and Month 6	DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from baseline to month 6 in aBMD was reported.
Maximum Blood Concentration (Cmax) of Ronacaleret	Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12	Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, Cmax of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.
Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12	Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods.
Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12	Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, AUC(0-t) and AUC(0-τ) of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.
Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Baseline (Day 0), Month 6 and Month 12	DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from baseline to month 6 and 12 in aBMD of hip (total hip, femoral neck and trochanter) were reported.
Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Baseline (Day 0), Month 5, 6 and 12	Responder rate of participants who remained the same or had any improvement as compared to baseline in DXA BMD of vertebra, femur and vertebra plus femur were reported. Baseline values were assessed on Day 0. Percent change (improvement) from Baseline was computed as (change from baseline / baseline value) \* 100%.
Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Baseline (Day 0) and Month 12	QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular volume of interest (VOI) are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm\^3 in contrast to DXA Which determines an areal density measured in g/cm\^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from Baseline to month 12 in the volumetric integral, cortical, and trabecular density (BMD) at the hip and lumbar spine measured by QCT were reported.
Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans	Baseline (Day 0) and Month 12	QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm\^3 in contrast to DXA Which determines an areal density measured in g/cm\^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%.
Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Baseline (Day 0) and Month 12	QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in mg/cm\^3 in contrast to DXA Which determines an areal density measured in g/cm\^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%.
Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Baseline (Day 0) and Month 12	Percent change in thickness of femur neck cortical VOI thickness and trochanter cortical VOI thickness were at Month 12 measured by QCT were reported. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%.
Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline (Day 0), Week 4, Month 3, 6, and 12	Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of CTX1.

Countries

Argentina, Australia, Belgium, Denmark, Germany, Hong Kong, Mexico, Norway, Poland, Russia, South Africa, South Korea, Spain, United States

Participant flow

Recruitment details

The study was conducted between 14-May-2007and 26-December-2008 at 45 centres in 14 countries.

Pre-assignment details

Of the 1609 participants screened, 1040 were screen failures, remaining 569 were randomized to the treatment arms. One participant from each of the 4 ronacaleret groups and alendronate group were excluded from Intent-to-Treat population and 564 participants were included in Intent-to-Treat population.

Participants by arm

Arm	Count
Placebo Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.	90
Ronacaleret, 100 mg Tablet, OD Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.	87
Ronacaleret, 200 mg Tablet, OD Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.	82
Ronacaleret, 300 mg Tablet, OD Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.	88
Ronacaleret, 400 mg Tablet, OD Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.	87
Alendronate, 70 mg, Capsule, OW Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.	89
Teriparatide, 20 mcg, SC Injection, OD Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.	41
Total	564

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Overall Study	Administration of prohibited medicine	0	0	0	0	1	0	0
Overall Study	Adverse Event	6	5	4	8	7	5	0
Overall Study	Early stopping due to non-efficacy	1	0	0	0	1	0	0
Overall Study	High parathyroid hormone	0	0	1	0	0	0	0
Overall Study	Lost to Follow-up	1	1	0	2	3	0	0
Overall Study	Met serum creatinine withdrawal criteria	1	0	2	2	0	0	0
Overall Study	Non-compliance	0	1	0	1	0	0	0
Overall Study	Participant lost medication	0	0	0	0	1	0	0
Overall Study	Participant planned to travel to abraod	1	0	0	0	0	1	0
Overall Study	Participant's decision	0	0	0	0	0	1	0
Overall Study	Participant shifted residence	0	0	0	0	1	0	0
Overall Study	Protocol Violation	3	6	3	2	2	4	1
Overall Study	Sponsor terminated study	20	23	19	22	18	24	0
Overall Study	Withdrawal by Subject	8	6	5	8	7	4	2

Baseline characteristics

Characteristic	Placebo	Ronacaleret, 100 mg Tablet, OD	Ronacaleret, 200 mg Tablet, OD	Ronacaleret, 300 mg Tablet, OD	Ronacaleret, 400 mg Tablet, OD	Alendronate, 70 mg, Capsule, OW	Teriparatide, 20 mcg, SC Injection, OD	Total
Age, Continuous	63.20 Years STANDARD_DEVIATION 6.75	64.17 Years STANDARD_DEVIATION 7.69	64.16 Years STANDARD_DEVIATION 7.03	64.34 Years STANDARD_DEVIATION 6.57	64.97 Years STANDARD_DEVIATION 7.6	65.11 Years STANDARD_DEVIATION 7.04	63.17 Years STANDARD_DEVIATION 5.92	64.24 Years STANDARD_DEVIATION 7.04
Race/Ethnicity, Customized African American/African Heritage	1 Participant	2 Participant	1 Participant	0 Participant	4 Participant	1 Participant	0 Participant	9 Participant
Race/Ethnicity, Customized African American/African Heritage & White	1 Participant	2 Participant	2 Participant	1 Participant	1 Participant	0 Participant	0 Participant	7 Participant
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participant	5 Participant	3 Participant	3 Participant	1 Participant	4 Participant	3 Participant	24 Participant
Race/Ethnicity, Customized Asian	10 Participant	7 Participant	10 Participant	11 Participant	10 Participant	8 Participant	3 Participant	59 Participant
Race/Ethnicity, Customized White	73 Participant	71 Participant	66 Participant	73 Participant	71 Participant	76 Participant	35 Participant	465 Participant
Sex: Female, Male Female	90 Participants	87 Participants	82 Participants	88 Participants	87 Participants	89 Participants	41 Participants	564 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	0 / 90	0 / 87	0 / 82	0 / 88	0 / 87	0 / 89	0 / 41
other Total, other adverse events	54 / 90	54 / 87	57 / 82	55 / 88	61 / 87	46 / 89	30 / 41
serious Total, serious adverse events	0 / 90	2 / 87	5 / 82	7 / 88	3 / 87	6 / 89	4 / 41

Outcome results

Primary

Mean Change From Baseline in Height

Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported.

Time frame: Baseline (Day 0), Month 6, 12 and early withdrawal

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Change From Baseline in Height	Early withdrawal	0.03 Centimeter	Standard Deviation 0.61
Placebo	Mean Change From Baseline in Height	Month 12	-0.14 Centimeter	Standard Deviation 0.65
Placebo	Mean Change From Baseline in Height	Month 6	-0.04 Centimeter	Standard Deviation 0.58
Ronacaleret, 100 mg Tablet, OD	Mean Change From Baseline in Height	Early withdrawal	0.17 Centimeter	Standard Deviation 1.92
Ronacaleret, 100 mg Tablet, OD	Mean Change From Baseline in Height	Month 12	0.04 Centimeter	Standard Deviation 1.59
Ronacaleret, 100 mg Tablet, OD	Mean Change From Baseline in Height	Month 6	0.17 Centimeter	Standard Deviation 1.41
Ronacaleret, 200 mg Tablet, OD	Mean Change From Baseline in Height	Month 12	0.02 Centimeter	Standard Deviation 0.76
Ronacaleret, 200 mg Tablet, OD	Mean Change From Baseline in Height	Early withdrawal	-0.13 Centimeter	Standard Deviation 0.55
Ronacaleret, 200 mg Tablet, OD	Mean Change From Baseline in Height	Month 6	0.72 Centimeter	Standard Deviation 3.82
Ronacaleret, 300 mg Tablet, OD	Mean Change From Baseline in Height	Early withdrawal	-0.16 Centimeter	Standard Deviation 0.76
Ronacaleret, 300 mg Tablet, OD	Mean Change From Baseline in Height	Month 6	0.05 Centimeter	Standard Deviation 0.7
Ronacaleret, 300 mg Tablet, OD	Mean Change From Baseline in Height	Month 12	-0.09 Centimeter	Standard Deviation 1.04
Ronacaleret, 400 mg Tablet, OD	Mean Change From Baseline in Height	Month 6	-0.04 Centimeter	Standard Deviation 0.82
Ronacaleret, 400 mg Tablet, OD	Mean Change From Baseline in Height	Early withdrawal	-0.16 Centimeter	Standard Deviation 0.82
Ronacaleret, 400 mg Tablet, OD	Mean Change From Baseline in Height	Month 12	-0.17 Centimeter	Standard Deviation 0.67
Alendronate, 70 mg, Capsule, OW	Mean Change From Baseline in Height	Month 12	-0.08 Centimeter	Standard Deviation 0.57
Alendronate, 70 mg, Capsule, OW	Mean Change From Baseline in Height	Early withdrawal	-0.37 Centimeter	Standard Deviation 0.88
Alendronate, 70 mg, Capsule, OW	Mean Change From Baseline in Height	Month 6	-0.07 Centimeter	Standard Deviation 1.13
Teriparatide, 20 mcg, SC Injection, OD	Mean Change From Baseline in Height	Early withdrawal	0 Centimeter	Standard Deviation 0
Teriparatide, 20 mcg, SC Injection, OD	Mean Change From Baseline in Height	Month 6	0.11 Centimeter	Standard Deviation 0.65
Teriparatide, 20 mcg, SC Injection, OD	Mean Change From Baseline in Height	Month 12	0.11 Centimeter	Standard Deviation 0.56

Primary

Mean Change From Baseline in Weight

Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported.

Time frame: Baseline (Day 0), Month 6, 12 and early withdrawal

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Change From Baseline in Weight	Early withdrawal	-0.45 Kilogram	Standard Deviation 2.4
Placebo	Mean Change From Baseline in Weight	Month 12	0.32 Kilogram	Standard Deviation 2.73
Placebo	Mean Change From Baseline in Weight	Month 6	-0.02 Kilogram	Standard Deviation 2.12
Ronacaleret, 100 mg Tablet, OD	Mean Change From Baseline in Weight	Month 12	-0.72 Kilogram	Standard Deviation 2.7
Ronacaleret, 100 mg Tablet, OD	Mean Change From Baseline in Weight	Month 6	0.27 Kilogram	Standard Deviation 3.27
Ronacaleret, 100 mg Tablet, OD	Mean Change From Baseline in Weight	Early withdrawal	0.40 Kilogram	Standard Deviation 4.6
Ronacaleret, 200 mg Tablet, OD	Mean Change From Baseline in Weight	Early withdrawal	-0.34 Kilogram	Standard Deviation 2.48
Ronacaleret, 200 mg Tablet, OD	Mean Change From Baseline in Weight	Month 6	0.45 Kilogram	Standard Deviation 2.98
Ronacaleret, 200 mg Tablet, OD	Mean Change From Baseline in Weight	Month 12	1.18 Kilogram	Standard Deviation 9.78
Ronacaleret, 300 mg Tablet, OD	Mean Change From Baseline in Weight	Month 12	-0.22 Kilogram	Standard Deviation 2.36
Ronacaleret, 300 mg Tablet, OD	Mean Change From Baseline in Weight	Month 6	-0.24 Kilogram	Standard Deviation 2.87
Ronacaleret, 300 mg Tablet, OD	Mean Change From Baseline in Weight	Early withdrawal	0.37 Kilogram	Standard Deviation 3.86
Ronacaleret, 400 mg Tablet, OD	Mean Change From Baseline in Weight	Month 12	-0.48 Kilogram	Standard Deviation 2.28
Ronacaleret, 400 mg Tablet, OD	Mean Change From Baseline in Weight	Month 6	0.11 Kilogram	Standard Deviation 2.84
Ronacaleret, 400 mg Tablet, OD	Mean Change From Baseline in Weight	Early withdrawal	0.00 Kilogram	Standard Deviation 2.17
Alendronate, 70 mg, Capsule, OW	Mean Change From Baseline in Weight	Month 6	0.29 Kilogram	Standard Deviation 1.89
Alendronate, 70 mg, Capsule, OW	Mean Change From Baseline in Weight	Early withdrawal	-0.12 Kilogram	Standard Deviation 2.33
Alendronate, 70 mg, Capsule, OW	Mean Change From Baseline in Weight	Month 12	0.57 Kilogram	Standard Deviation 3.22
Teriparatide, 20 mcg, SC Injection, OD	Mean Change From Baseline in Weight	Early withdrawal	-2.15 Kilogram	Standard Deviation 1.48
Teriparatide, 20 mcg, SC Injection, OD	Mean Change From Baseline in Weight	Month 12	0.09 Kilogram	Standard Deviation 2.45
Teriparatide, 20 mcg, SC Injection, OD	Mean Change From Baseline in Weight	Month 6	0.51 Kilogram	Standard Deviation 1.84

Primary

Number of Participants Withdrew Due to Hypercalcemia

A confirmed albumin-adjusted serum calcium pre-dose value of \>11.0 mg/dL or post-dose value of \>12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported.

Time frame: Up to Month 12

Population: Intent-to-Treat population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Withdrew Due to Hypercalcemia	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Withdrew Due to Hypercalcemia	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Withdrew Due to Hypercalcemia	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Withdrew Due to Hypercalcemia	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Withdrew Due to Hypercalcemia	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Withdrew Due to Hypercalcemia	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Withdrew Due to Hypercalcemia	0 Participants

Primary

Number of Participants With Hypercalcemia

Participants with albumin-adjusted serum calcium pre-dose values of \>11.0 mg/ deciliter (dL) or post-dose values of \>12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported.

Time frame: Up to Month 12

Population: Intent-to-Treat population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Hypercalcemia	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants With Hypercalcemia	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants With Hypercalcemia	1 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants With Hypercalcemia	4 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants With Hypercalcemia	11 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants With Hypercalcemia	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants With Hypercalcemia	1 Participants

Primary

Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event

Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett's correction) interval, QTcF (Fridericia's correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study.

Time frame: Up to 12 months

Population: Intent-to-Treat population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event	1 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event	5 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event	4 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event	3 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event	3 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event	5 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event	0 Participants

Primary

Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit

The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported.

Time frame: Up to Month 12

Population: Intent-to-Treat population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- low	3 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- high	9 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- low	16 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- high	1 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Alkaline Phosphatase- high	0 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Monocytes- high	17 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Platelets- high	2 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- low	2 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- high	1 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Calcium- high	0 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- low	1 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hematocrit- low	2 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Basophils- high	2 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total bilirubin- high	0 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- high	10 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Phosphorus- high	1 Participants
Placebo	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Eosinophils- high	12 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Monocytes- high	14 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- low	1 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Calcium- high	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- low	5 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- high	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Eosinophils- high	8 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- high	6 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total bilirubin- high	1 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- low	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Basophils- high	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hematocrit- low	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Phosphorus- high	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- low	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- high	11 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Alkaline Phosphatase- high	1 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Platelets- high	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- high	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Platelets- high	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Basophils- high	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- high	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Alkaline Phosphatase- high	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Eosinophils- high	11 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Phosphorus- high	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Calcium- high	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total bilirubin- high	2 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hematocrit- low	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- low	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- low	8 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- low	4 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- high	10 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- low	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- high	2 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Monocytes- high	19 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- high	9 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- low	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Monocytes- high	17 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Phosphorus- high	1 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- high	5 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- high	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Calcium- high	1 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Basophils- high	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- high	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Platelets- high	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hematocrit- low	2 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Alkaline Phosphatase- high	3 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- low	2 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- high	10 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- low	2 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- low	8 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total bilirubin- high	1 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Eosinophils- high	18 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Calcium- high	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- low	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- low	3 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- high	4 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- high	4 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total bilirubin- high	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Eosinophils- high	19 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Monocytes- high	18 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- high	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- low	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hematocrit- low	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Platelets- high	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- low	14 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Alkaline Phosphatase- high	3 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- high	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Phosphorus- high	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Basophils- high	1 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Phosphorus- high	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- high	6 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total bilirubin- high	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Monocytes- high	28 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- low	13 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Eosinophils- high	11 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- high	5 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- low	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Basophils- high	1 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hematocrit- low	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- high	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- low	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Platelets- high	1 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- high	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- low	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Calcium- high	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Alkaline Phosphatase- high	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- low	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	White Blood Cell- high	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Monocytes- high	6 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Phosphorus- high	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Platelets- high	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- low	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hemoglobin- high	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Hematocrit- low	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Basophils- high	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total bilirubin- high	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Alkaline Phosphatase- high	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- low	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Glucose- high	3 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Eosinophils- high	6 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- low	4 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Total neutrophils- high	4 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit	Calcium- high	0 Participants

Primary

Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit

The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (\> 30 millimeter of mercury \[mmHg\] decrease from Baseline, \> 30 mmHg increase from Baseline), diastolic blood pressure (\> 20 mmHg decrease from Baseline and \> 20 mmHg increase from Baseline) and heart rate (\<45 and \>120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.

Time frame: Up to 12 Months

Population: Intent-to-Treat population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, High	2 Participants
Placebo	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Heart Rate, Low	2 Participants
Placebo	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, Low	6 Participants
Placebo	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, High	5 Participants
Placebo	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, Low	8 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Heart Rate, Low	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, Low	9 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, Low	8 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, High	6 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, High	10 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Heart Rate, Low	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, Low	4 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, High	5 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, High	8 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, Low	10 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, High	1 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, High	9 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, Low	6 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, Low	12 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Heart Rate, Low	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, High	11 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Heart Rate, Low	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, High	6 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, Low	10 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, Low	4 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, High	8 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Heart Rate, Low	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, Low	10 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, Low	8 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, High	3 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, Low	2 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, Low	3 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Diastolic Blood Pressure, High	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Systolic Blood Pressure, High	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit	Heart Rate, Low	0 Participants

Primary

Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)

DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported.

Time frame: Baseline (Day 0) and 12 Months

Population: Intent-to-Treat population comprised of any randomised or teriparatide participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed. Teriparatide arm was excluded from the analysis, since these participants were not randomized and were disproportionately represented.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)	0.03 Percent change in BMD	Standard Error 0.38
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)	0.32 Percent change in BMD	Standard Error 0.4
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)	1.39 Percent change in BMD	Standard Error 0.4
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)	1.61 Percent change in BMD	Standard Error 0.39
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)	1.62 Percent change in BMD	Standard Error 0.4
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)	4.54 Percent change in BMD	Standard Error 0.4

p-value: 0.5995% CI: [-0.78, 1.37]ANOVA

p-value: 0.02895% CI: [0.28, 2.44]ANOVA

p-value: 0.01195% CI: [0.51, 2.65]ANOVA

p-value: 0.01295% CI: [0.51, 2.69]ANOVA

Secondary

Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret

Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, AUC(0-t) and AUC(0-τ) of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.

Time frame: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

Population: Pharmacokinetic Parameters Population comprised of any participant in the pharmacokinetic concentration population who provided pharmacokinetic parameters. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-t, Month 6	2495.8751 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 53.13
Placebo	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-t, Month 12	2766.6822 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 64.2
Placebo	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-tau, Month 6	3628.0901 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 66.72
Placebo	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-tau, Month 12	3922.9369 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 75.72
Ronacaleret, 100 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-tau, Month 12	6455.1756 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 42.03
Ronacaleret, 100 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-tau, Month 6	6428.5540 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 36.62
Ronacaleret, 100 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-t, Month 12	4548.6490 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 43.87
Ronacaleret, 100 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-t, Month 6	4575.8746 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 35.5
Ronacaleret, 200 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-tau, Month 6	10825.9083 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 50.48
Ronacaleret, 200 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-tau, Month 12	14827.6940 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 38.28
Ronacaleret, 200 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-t, Month 12	9259.3127 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 37.74
Ronacaleret, 200 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-t, Month 6	7545.3302 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 42.26
Ronacaleret, 300 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-tau, Month 12	10079.2847 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 71.01
Ronacaleret, 300 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-t, Month 6	6712.0537 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 79.69
Ronacaleret, 300 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-t, Month 12	6798.4219 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 65.17
Ronacaleret, 300 mg Tablet, OD	Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret	AUC 0-tau, Month 6	9810.4614 nanogramhour per millilitre (nghr/mL)	Geometric Coefficient of Variation 80.08

Secondary

Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of BALP.

Time frame: Baseline (Day 0), Week 4, Month 3, 6, and 12

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline	14.46 mcg/L	Standard Error 1.04
Placebo	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12	13.25 mcg/L	Standard Error 1.04
Placebo	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3	12.66 mcg/L	Standard Error 1.04
Placebo	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4	14.02 mcg/L	Standard Error 1.04
Placebo	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6	12.81 mcg/L	Standard Error 1.04
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3, Placebo contrast	1.20 mcg/L	Standard Error 1.06
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline, Placebo contrast	1.03 mcg/L	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6, Placebo contrast	1.27 mcg/L	Standard Error 1.06
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3	15.23 mcg/L	Standard Error 1.04
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12, Placebo contrast	1.26 mcg/L	Standard Error 1.06
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4	14.72 mcg/L	Standard Error 1.04
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline	14.96 mcg/L	Standard Error 1.04
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12	16.64 mcg/L	Standard Error 1.04
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6	16.31 mcg/L	Standard Error 1.04
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4, Placebo contrast	1.05 mcg/L	Standard Error 1.05
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3, Placebo contrast	1.22 mcg/L	Standard Error 1.06
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6	17.43 mcg/L	Standard Error 1.04
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline, Placebo contrast	0.98 mcg/L	Standard Error 1.05
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12, Placebo contrast	1.42 mcg/L	Standard Error 1.06
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4	14.51 mcg/L	Standard Error 1.04
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12	18.80 mcg/L	Standard Error 1.04
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4, Placebo contrast	1.03 mcg/L	Standard Error 1.06
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline	14.24 mcg/L	Standard Error 1.04
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3	15.44 mcg/L	Standard Error 1.04
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6, Placebo contrast	1.36 mcg/L	Standard Error 1.06
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4	15.97 mcg/L	Standard Error 1.04
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline, Placebo contrast	1.04 mcg/L	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6	22.18 mcg/L	Standard Error 1.04
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12, Placebo contrast	1.76 mcg/L	Standard Error 1.06
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3	18.77 mcg/L	Standard Error 1.04
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline	15.06 mcg/L	Standard Error 1.04
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6, Placebo contrast	1.73 mcg/L	Standard Error 1.06
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4, Placebo contrast	1.14 mcg/L	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3, Placebo contrast	1.48 mcg/L	Standard Error 1.06
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12	23.36 mcg/L	Standard Error 1.04
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12	23.28 mcg/L	Standard Error 1.04
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline	14.12 mcg/L	Standard Error 1.04
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline, Placebo contrast	0.98 mcg/L	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4	15.72 mcg/L	Standard Error 1.04
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4, Placebo contrast	1.12 mcg/L	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3	17.85 mcg/L	Standard Error 1.04
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3, Placebo contrast	1.41 mcg/L	Standard Error 1.06
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6	21.47 mcg/L	Standard Error 1.04
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6, Placebo contrast	1.68 mcg/L	Standard Error 1.06
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12, Placebo contrast	1.76 mcg/L	Standard Error 1.06
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6	8.36 mcg/L	Standard Error 1.04
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3, Placebo contrast	0.75 mcg/L	Standard Error 1.06
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3	9.44 mcg/L	Standard Error 1.04
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12, Placebo contrast	0.64 mcg/L	Standard Error 1.06
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6, Placebo contrast	0.65 mcg/L	Standard Error 1.06
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4, Placebo contrast	0.98 mcg/L	Standard Error 1.05
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4	13.68 mcg/L	Standard Error 1.04
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline	14.31 mcg/L	Standard Error 1.04
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12	8.42 mcg/L	Standard Error 1.04
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline, Placebo contrast	0.99 mcg/L	Standard Error 1.05
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline	14.50 mcg/L	Standard Error 1.05
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3, Placebo contrast	1.31 mcg/L	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 3	16.53 mcg/L	Standard Error 1.06
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12, Placebo contrast	1.44 mcg/L	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 12	19.08 mcg/L	Standard Error 1.06
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Baseline, Placebo contrast	1.00 mcg/L	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6, Placebo contrast	1.38 mcg/L	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4, Placebo contrast	1.15 mcg/L	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Month 6	17.63 mcg/L	Standard Error 1.06
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)	Week 4	16.19 mcg/L	Standard Error 1.06

Secondary

Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of CTX1.

Time frame: Baseline (Day 0), Week 4, Month 3, 6, and 12

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12	525.1 nanogram per litre (ng/L)	Standard Error 1.08
Placebo	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4	530.7 nanogram per litre (ng/L)	Standard Error 1.05
Placebo	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline	625.2 nanogram per litre (ng/L)	Standard Error 1.05
Placebo	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6	517.6 nanogram per litre (ng/L)	Standard Error 1.06
Placebo	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3	523.5 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4, Placebo contrast	0.97 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3, Placebo contrast	1.14 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12, Placebo contrast	1.32 nanogram per litre (ng/L)	Standard Error 1.12
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline, Placebo contrast	1.02 nanogram per litre (ng/L)	Standard Error 1.07
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6, Placebo contrast	1.25 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline	635.3 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3	598.5 nanogram per litre (ng/L)	Standard Error 1.06
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12	695.2 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4	515.2 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6	648.2 nanogram per litre (ng/L)	Standard Error 1.06
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3	688.9 nanogram per litre (ng/L)	Standard Error 1.06
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6	777.1 nanogram per litre (ng/L)	Standard Error 1.06
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3, Placebo contrast	1.32 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline	632.0 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12, Placebo contrast	1.54 nanogram per litre (ng/L)	Standard Error 1.11
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline, Placebo contrast	1.01 nanogram per litre (ng/L)	Standard Error 1.07
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12	806.1 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4	525.4 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6, Placebo contrast	1.50 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4, Placebo contrast	0.99 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3, Placebo contrast	1.38 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4	506.1 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3	723.2 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4, Placebo contrast	0.95 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12	852.8 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline, Placebo contrast	0.94 nanogram per litre (ng/L)	Standard Error 1.07
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6	859.6 nanogram per litre (ng/L)	Standard Error 1.06
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline	587.9 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12, Placebo contrast	1.62 nanogram per litre (ng/L)	Standard Error 1.12
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6, Placebo contrast	1.66 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline, Placebo contrast	1.03 nanogram per litre (ng/L)	Standard Error 1.07
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12	991.9 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12, Placebo contrast	1.89 nanogram per litre (ng/L)	Standard Error 1.11
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline	645.5 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6	964.3 nanogram per litre (ng/L)	Standard Error 1.06
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4	529.2 nanogram per litre (ng/L)	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4, Placebo contrast	1.00 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3	818.9 nanogram per litre (ng/L)	Standard Error 1.06
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3, Placebo contrast	1.56 nanogram per litre (ng/L)	Standard Error 1.08
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6, Placebo contrast	1.86 nanogram per litre (ng/L)	Standard Error 1.08
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3, Placebo contrast	0.49 nanogram per litre (ng/L)	Standard Error 1.08
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3	257.1 nanogram per litre (ng/L)	Standard Error 1.06
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6	235.9 nanogram per litre (ng/L)	Standard Error 1.07
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4, Placebo contrast	0.54 nanogram per litre (ng/L)	Standard Error 1.08
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4	288.0 nanogram per litre (ng/L)	Standard Error 1.06
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6, Placebo contrast	0.46 nanogram per litre (ng/L)	Standard Error 1.09
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline, Placebo contrast	1.01 nanogram per litre (ng/L)	Standard Error 1.07
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12	158.3 nanogram per litre (ng/L)	Standard Error 1.08
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline	630.4 nanogram per litre (ng/L)	Standard Error 1.05
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12, Placebo contrast	0.30 nanogram per litre (ng/L)	Standard Error 1.11
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12	1071 nanogram per litre (ng/L)	Standard Error 1.1
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3	864.1 nanogram per litre (ng/L)	Standard Error 1.08
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6, Placebo contrast	2.15 nanogram per litre (ng/L)	Standard Error 1.1
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4, Placebo contrast	1.09 nanogram per litre (ng/L)	Standard Error 1.1
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline, Placebo contrast	0.90 nanogram per litre (ng/L)	Standard Error 1.09
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 6	1112 nanogram per litre (ng/L)	Standard Error 1.08
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Baseline	564.0 nanogram per litre (ng/L)	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Week 4	576.1 nanogram per litre (ng/L)	Standard Error 1.08
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 3, Placebo contrast	1.65 nanogram per litre (ng/L)	Standard Error 1.1
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)	Month 12, Placebo contrast	2.04 nanogram per litre (ng/L)	Standard Error 1.13

Secondary

Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of P1NP.

Time frame: Baseline (Day 0), Week 4, Month 3, 6, and 12

Population: Intent to treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4	45.32 Microgram per Litre (mcg/L)	Standard Error 1.05
Placebo	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12	40.74 Microgram per Litre (mcg/L)	Standard Error 1.05
Placebo	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline	47.66 Microgram per Litre (mcg/L)	Standard Error 1.05
Placebo	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3	39.53 Microgram per Litre (mcg/L)	Standard Error 1.05
Placebo	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6	38.41 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4	49.67 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3	49.99 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6, Placebo contrast	1.47 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline, Placebo contrast	0.96 Microgram per Litre (mcg/L)	Standard Error 1.07
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3, Placebo contrast	1.26 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline	45.59 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6	56.37 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12	61.43 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4, Placebo contrast	1.10 Microgram per Litre (mcg/L)	Standard Error 1.07
Ronacaleret, 100 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12, Placebo contrast	1.51 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3, Placebo contrast	1.65 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline	47.70 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6	75.73 Microgram per Litre (mcg/L)	Standard Error 1.06
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12, Placebo contrast	2.03 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline, Placebo contrast	1.00 Microgram per Litre (mcg/L)	Standard Error 1.07
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4	57.36 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12	82.69 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4, Placebo contrast	1.27 Microgram per Litre (mcg/L)	Standard Error 1.07
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3	65.21 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 200 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6, Placebo contrast	1.97 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4	60.27 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6, Placebo contrast	2.36 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline, Placebo contrast	0.98 Microgram per Litre (mcg/L)	Standard Error 1.07
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12, Placebo contrast	2.41 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6	90.55 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3	73.68 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline	46.62 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3, Placebo contrast	1.86 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4, Placebo contrast	1.33 Microgram per Litre (mcg/L)	Standard Error 1.07
Ronacaleret, 300 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12	98.04 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12	112.6 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline	46.19 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline, Placebo contrast	0.97 Microgram per Litre (mcg/L)	Standard Error 1.07
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4	63.46 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4, Placebo contrast	1.40 Microgram per Litre (mcg/L)	Standard Error 1.07
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3	86.84 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3, Placebo contrast	2.20 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6	104.6 Microgram per Litre (mcg/L)	Standard Error 1.05
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6, Placebo contrast	2.72 Microgram per Litre (mcg/L)	Standard Error 1.08
Ronacaleret, 400 mg Tablet, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12, Placebo contrast	2.76 Microgram per Litre (mcg/L)	Standard Error 1.08
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6	16.41 Microgram per Litre (mcg/L)	Standard Error 1.05
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3	20.15 Microgram per Litre (mcg/L)	Standard Error 1.05
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12, Placebo contrast	0.42 Microgram per Litre (mcg/L)	Standard Error 1.08
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6, Placebo contrast	0.43 Microgram per Litre (mcg/L)	Standard Error 1.08
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4, Placebo contrast	0.96 Microgram per Litre (mcg/L)	Standard Error 1.07
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4	43.66 Microgram per Litre (mcg/L)	Standard Error 1.05
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12	16.98 Microgram per Litre (mcg/L)	Standard Error 1.05
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline, Placebo contrast	1.00 Microgram per Litre (mcg/L)	Standard Error 1.07
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline	47.71 Microgram per Litre (mcg/L)	Standard Error 1.05
Alendronate, 70 mg, Capsule, OW	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3, Placebo contrast	0.51 Microgram per Litre (mcg/L)	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline	48.57 Microgram per Litre (mcg/L)	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6	117.8 Microgram per Litre (mcg/L)	Standard Error 1.08
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3	99.74 Microgram per Litre (mcg/L)	Standard Error 1.08
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Baseline, Placebo contrast	1.02 Microgram per Litre (mcg/L)	Standard Error 1.08
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4, Placebo contrast	2.05 Microgram per Litre (mcg/L)	Standard Error 1.09
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12, Placebo contrast	2.92 Microgram per Litre (mcg/L)	Standard Error 1.09
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 12	119.0 Microgram per Litre (mcg/L)	Standard Error 1.07
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 6, Placebo contrast	3.07 Microgram per Litre (mcg/L)	Standard Error 1.09
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Month 3, Placebo contrast	2.52 Microgram per Litre (mcg/L)	Standard Error 1.09
Teriparatide, 20 mcg, SC Injection, OD	Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)	Week 4	92.74 Microgram per Litre (mcg/L)	Standard Error 1.07

Secondary

Blood Concentrations of Ronacaleret

Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Blood concentrations of ronacaleret were reported.

Time frame: Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

Population: Pharmacokinetic Concentration Population comprised of any Intent-to-Treat participants for whom a SB-751689 pharmacokinetic blood sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Blood Concentrations of Ronacaleret	Week 4, Pre-dose	41.22 nanograms per millilitre (ng/mL)	Standard Deviation 127.438
Placebo	Blood Concentrations of Ronacaleret	Week 4, 8-12 h post dose	204.82 nanograms per millilitre (ng/mL)	Standard Deviation 183.245
Placebo	Blood Concentrations of Ronacaleret	Month 6, Pre-dose	21.37 nanograms per millilitre (ng/mL)	Standard Deviation 19.769
Placebo	Blood Concentrations of Ronacaleret	Month 6, 1-4 h post dose	644.90 nanograms per millilitre (ng/mL)	Standard Deviation 408.282
Placebo	Blood Concentrations of Ronacaleret	Month 6, 8-12 h post dose	186.69 nanograms per millilitre (ng/mL)	Standard Deviation 101.326
Placebo	Blood Concentrations of Ronacaleret	Month 6, 24 h post dose	186.21 nanograms per millilitre (ng/mL)	Standard Deviation 151.855
Placebo	Blood Concentrations of Ronacaleret	Month 12, Pre-dose	20.68 nanograms per millilitre (ng/mL)	Standard Deviation 15.971
Placebo	Blood Concentrations of Ronacaleret	Month 12, 1-4 h post dose	779.92 nanograms per millilitre (ng/mL)	Standard Deviation 465.356
Placebo	Blood Concentrations of Ronacaleret	Month 12, 8-12 h post dose	203.39 nanograms per millilitre (ng/mL)	Standard Deviation 124.866
Placebo	Blood Concentrations of Ronacaleret	Month 12, 24 h post dose	187.23 nanograms per millilitre (ng/mL)	Standard Deviation 100.001
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, Pre-dose	65.94 nanograms per millilitre (ng/mL)	Standard Deviation 214.325
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 8-12 h post dose	262.20 nanograms per millilitre (ng/mL)	Standard Deviation 137.152
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 1-4 h post dose	1308.35 nanograms per millilitre (ng/mL)	Standard Deviation 943.397
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 8-12 h post dose	385.03 nanograms per millilitre (ng/mL)	Standard Deviation 284.963
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 24 h post dose	290.74 nanograms per millilitre (ng/mL)	Standard Deviation 125.486
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, Pre-dose	33.47 nanograms per millilitre (ng/mL)	Standard Deviation 26.747
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 24 h post dose	297.20 nanograms per millilitre (ng/mL)	Standard Deviation 146.806
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 1-4 h post dose	999.63 nanograms per millilitre (ng/mL)	Standard Deviation 659.88
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Week 4, Pre-dose	37.24 nanograms per millilitre (ng/mL)	Standard Deviation 36.203
Ronacaleret, 100 mg Tablet, OD	Blood Concentrations of Ronacaleret	Week 4, 8-12 h post dose	328.33 nanograms per millilitre (ng/mL)	Standard Deviation 222.061
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 1-4 h post dose	1819.53 nanograms per millilitre (ng/mL)	Standard Deviation 1021.984
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, Pre-dose	147.63 nanograms per millilitre (ng/mL)	Standard Deviation 370.86
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 24 h post dose	626.72 nanograms per millilitre (ng/mL)	Standard Deviation 231.777
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Week 4, Pre-dose	85.44 nanograms per millilitre (ng/mL)	Standard Deviation 158.849
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 1-4 h post dose	1610.74 nanograms per millilitre (ng/mL)	Standard Deviation 1016.608
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 24 h post dose	578.63 nanograms per millilitre (ng/mL)	Standard Deviation 398.915
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 8-12 h post dose	651.95 nanograms per millilitre (ng/mL)	Standard Deviation 391.752
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Week 4, 8-12 h post dose	581.08 nanograms per millilitre (ng/mL)	Standard Deviation 360.031
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 8-12 h post dose	576.35 nanograms per millilitre (ng/mL)	Standard Deviation 382.494
Ronacaleret, 200 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, Pre-dose	74.12 nanograms per millilitre (ng/mL)	Standard Deviation 146.094
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 8-12 h post dose	796.99 nanograms per millilitre (ng/mL)	Standard Deviation 640.016
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 1-4 h post dose	2128.24 nanograms per millilitre (ng/mL)	Standard Deviation 1549.003
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 24 h post dose	473.41 nanograms per millilitre (ng/mL)	Standard Deviation 237.671
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 24 h post dose	512.65 nanograms per millilitre (ng/mL)	Standard Deviation 314.692
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, Pre-dose	114.83 nanograms per millilitre (ng/mL)	Standard Deviation 179.448
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Week 4, 8-12 h post dose	685.14 nanograms per millilitre (ng/mL)	Standard Deviation 450.467
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, Pre-dose	117.94 nanograms per millilitre (ng/mL)	Standard Deviation 288.413
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 6, 1-4 h post dose	2054.71 nanograms per millilitre (ng/mL)	Standard Deviation 1499.079
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Week 4, Pre-dose	79.40 nanograms per millilitre (ng/mL)	Standard Deviation 74.083
Ronacaleret, 300 mg Tablet, OD	Blood Concentrations of Ronacaleret	Month 12, 8-12 h post dose	740.18 nanograms per millilitre (ng/mL)	Standard Deviation 679.348

Secondary

Maximum Blood Concentration (Cmax) of Ronacaleret

Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, Cmax of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.

Time frame: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

Population: Pharmacokinetic parameter population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	Maximum Blood Concentration (Cmax) of Ronacaleret	Cmax. Month 12	661.70 ng/mL	Geometric Coefficient of Variation 74.39
Placebo	Maximum Blood Concentration (Cmax) of Ronacaleret	Cmax. Month 6	572.10 ng/mL	Geometric Coefficient of Variation 44.79
Ronacaleret, 100 mg Tablet, OD	Maximum Blood Concentration (Cmax) of Ronacaleret	Cmax. Month 6	1050.42 ng/mL	Geometric Coefficient of Variation 40.82
Ronacaleret, 100 mg Tablet, OD	Maximum Blood Concentration (Cmax) of Ronacaleret	Cmax. Month 12	999.91 ng/mL	Geometric Coefficient of Variation 37.18
Ronacaleret, 200 mg Tablet, OD	Maximum Blood Concentration (Cmax) of Ronacaleret	Cmax. Month 6	1756.45 ng/mL	Geometric Coefficient of Variation 52.8
Ronacaleret, 200 mg Tablet, OD	Maximum Blood Concentration (Cmax) of Ronacaleret	Cmax. Month 12	2254.26 ng/mL	Geometric Coefficient of Variation 41.57
Ronacaleret, 300 mg Tablet, OD	Maximum Blood Concentration (Cmax) of Ronacaleret	Cmax. Month 12	1506.45 ng/mL	Geometric Coefficient of Variation 63.78
Ronacaleret, 300 mg Tablet, OD	Maximum Blood Concentration (Cmax) of Ronacaleret	Cmax. Month 6	1556.58 ng/mL	Geometric Coefficient of Variation 76.83

Secondary

Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)

Responder rate of participants who remained the same or had any improvement as compared to baseline in DXA BMD of vertebra, femur and vertebra plus femur were reported. Baseline values were assessed on Day 0. Percent change (improvement) from Baseline was computed as (change from baseline / baseline value) \* 100%.

Time frame: Baseline (Day 0), Month 5, 6 and 12

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra, BMD % change >=0	0 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Femur, BMD % change >=0	0 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Femur, BMD % change >=0	0 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra, BMD % change >=0	1 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra, BMD % change >=0	0 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra + Femur, BMD % change >=0	0 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Femur, BMD % change >=0	1 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra, BMD % change >=0	16 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra + Femur, BMD % change >=0	10 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Femur, BMD % change >=0	20 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra + Femur, BMD %change>=0	1 Participants
Placebo	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra + Femur, BMD % change >=0	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Femur, BMD % change >=0	23 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra + Femur, BMD % change >=0	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra, BMD % change >=0	29 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra + Femur, BMD %change>=0	1 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra, BMD % change >=0	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra + Femur, BMD % change >=0	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Femur, BMD % change >=0	1 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra, BMD % change >=0	1 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra, BMD % change >=0	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Femur, BMD % change >=0	0 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra + Femur, BMD % change >=0	19 Participants
Ronacaleret, 100 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Femur, BMD % change >=0	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Femur, BMD % change >=0	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra, BMD % change >=0	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Femur, BMD % change >=0	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra, BMD % change >=0	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Femur, BMD % change >=0	14 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra + Femur, BMD %change>=0	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra, BMD % change >=0	32 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra + Femur, BMD % change >=0	12 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra + Femur, BMD % change >=0	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra, BMD % change >=0	1 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra + Femur, BMD % change >=0	0 Participants
Ronacaleret, 200 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Femur, BMD % change >=0	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Femur, BMD % change >=0	1 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra + Femur, BMD % change >=0	17 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Femur, BMD % change >=0	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra, BMD % change >=0	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra + Femur, BMD % change >=0	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra, BMD % change >=0	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Femur, BMD % change >=0	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra + Femur, BMD % change >=0	0 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra, BMD % change >=0	35 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Femur, BMD % change >=0	19 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra, BMD % change >=0	2 Participants
Ronacaleret, 300 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra + Femur, BMD %change>=0	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra + Femur, BMD % change >=0	16 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Femur, BMD % change >=0	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra + Femur, BMD % change >=0	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra, BMD % change >=0	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra, BMD % change >=0	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra + Femur, BMD %change>=0	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra, BMD % change >=0	31 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Femur, BMD % change >=0	16 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Femur, BMD % change >=0	0 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Femur, BMD % change >=0	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra, BMD % change >=0	1 Participants
Ronacaleret, 400 mg Tablet, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra + Femur, BMD % change >=0	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra + Femur, BMD %change>=0	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra, BMD % change >=0	44 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Femur, BMD % change >=0	1 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Femur, BMD % change >=0	40 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra, BMD % change >=0	1 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra + Femur, BMD % change >=0	35 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra + Femur, BMD % change >=0	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra, BMD % change >=0	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra, BMD % change >=0	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Femur, BMD % change >=0	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Femur, BMD % change >=0	0 Participants
Alendronate, 70 mg, Capsule, OW	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra + Femur, BMD % change >=0	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra + Femur, BMD % change >=0	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Vertebra, BMD % change >=0	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Femur, BMD % change >=0	25 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra + Femur, BMD %change>=0	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Femur, BMD % change >=0	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Femur, BMD % change >=0	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra, BMD % change >=0	34 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra + Femur, BMD % change >=0	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 6, Femur, BMD % change >=0	0 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Early Withdrawal, Vertebra, BMD % change >=0	1 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 12, Vertebra + Femur, BMD % change >=0	24 Participants
Teriparatide, 20 mcg, SC Injection, OD	Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)	Month 5, Vertebra, BMD % change >=0	0 Participants

Secondary

Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans

Percent change in thickness of femur neck cortical VOI thickness and trochanter cortical VOI thickness were at Month 12 measured by QCT were reported. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%.

Time frame: Baseline (Day 0) and Month 12

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Neck cortical VOI Thickness	-0.85 Percent change in cortical thickness	Standard Deviation 7.09
Placebo	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Trochanter cortical VOI Thickness	-1.00 Percent change in cortical thickness	Standard Deviation 5.85
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Neck cortical VOI Thickness	-0.13 Percent change in cortical thickness	Standard Deviation 5.98
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Trochanter cortical VOI Thickness	0.76 Percent change in cortical thickness	Standard Deviation 4.4
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Neck cortical VOI Thickness	1.12 Percent change in cortical thickness	Standard Deviation 5.75
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Trochanter cortical VOI Thickness	1.01 Percent change in cortical thickness	Standard Deviation 5.15
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Neck cortical VOI Thickness	-0.88 Percent change in cortical thickness	Standard Deviation 4.73
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Trochanter cortical VOI Thickness	-0.82 Percent change in cortical thickness	Standard Deviation 3.65
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Neck cortical VOI Thickness	0.32 Percent change in cortical thickness	Standard Deviation 4.93
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Trochanter cortical VOI Thickness	1.60 Percent change in cortical thickness	Standard Deviation 3.7
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Neck cortical VOI Thickness	-0.13 Percent change in cortical thickness	Standard Deviation 5.98
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Trochanter cortical VOI Thickness	0.81 Percent change in cortical thickness	Standard Deviation 5.39
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Neck cortical VOI Thickness	0.39 Percent change in cortical thickness	Standard Deviation 4.36
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans	Trochanter cortical VOI Thickness	0.76 Percent change in cortical thickness	Standard Deviation 2.93

Secondary

Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans

QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm\^3 in contrast to DXA Which determines an areal density measured in g/cm\^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%.

Time frame: Baseline (Day 0) and Month 12

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans	0.04 Percent change in VOI	Standard Deviation 4.19
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans	0.85 Percent change in VOI	Standard Deviation 4.14
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans	3.01 Percent change in VOI	Standard Deviation 5.18
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans	3.58 Percent change in VOI	Standard Deviation 5.7
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans	3.54 Percent change in VOI	Standard Deviation 5.64
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans	5.39 Percent change in VOI	Standard Deviation 5.87
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans	12.23 Percent change in VOI	Standard Deviation 8.43

Secondary

Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans

QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular volume of interest (VOI) are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm\^3 in contrast to DXA Which determines an areal density measured in g/cm\^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from Baseline to month 12 in the volumetric integral, cortical, and trabecular density (BMD) at the hip and lumbar spine measured by QCT were reported.

Time frame: Baseline (Day 0) and Month 12

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Cylinder trabecular VOI BMD	-2.45 Percent change in BMD	Standard Deviation 4.39
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra trabecular VOI BMD	-2.46 Percent change in BMD	Standard Deviation 4.58
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra integral VOI BMD	-0.98 Percent change in BMD	Standard Deviation 3.13
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid vertebra integral VOI BMD	-1.31 Percent change in BMD	Standard Deviation 3.54
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo cortical VOI BMD	-0.30 Percent change in BMD	Standard Deviation 4.69
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo trabecular VOI BMD	-2.21 Percent change in BMD	Standard Deviation 4.58
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra integral VOI BMD	1.09 Percent change in BMD	Standard Deviation 4.01
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid vertebra integral VOI BMD	1.20 Percent change in BMD	Standard Deviation 4.85
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra trabecular VOI BMD	1.67 Percent change in BMD	Standard Deviation 7.18
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo trabecular VOI BMD	1.81 Percent change in BMD	Standard Deviation 8.26
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Cylinder trabecular VOI BMD	1.75 Percent change in BMD	Standard Deviation 8.7
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo cortical VOI BMD	0.63 Percent change in BMD	Standard Deviation 4.8
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra integral VOI BMD	3.00 Percent change in BMD	Standard Deviation 4.98
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo trabecular VOI BMD	7.06 Percent change in BMD	Standard Deviation 9.25
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Cylinder trabecular VOI BMD	6.17 Percent change in BMD	Standard Deviation 10.37
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo cortical VOI BMD	2.37 Percent change in BMD	Standard Deviation 6.37
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra trabecular VOI BMD	5.81 Percent change in BMD	Standard Deviation 8.31
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid vertebra integral VOI BMD	4.65 Percent change in BMD	Standard Deviation 5.87
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra trabecular VOI BMD	8.52 Percent change in BMD	Standard Deviation 8.97
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra integral VOI BMD	3.91 Percent change in BMD	Standard Deviation 4.98
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Cylinder trabecular VOI BMD	8.99 Percent change in BMD	Standard Deviation 10.52
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo trabecular VOI BMD	9.54 Percent change in BMD	Standard Deviation 9.79
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo cortical VOI BMD	2.57 Percent change in BMD	Standard Deviation 5.14
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid vertebra integral VOI BMD	6.06 Percent change in BMD	Standard Deviation 6.48
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra integral VOI BMD	4.83 Percent change in BMD	Standard Deviation 6.56
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo trabecular VOI BMD	13.21 Percent change in BMD	Standard Deviation 14.68
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra trabecular VOI BMD	11.40 Percent change in BMD	Standard Deviation 12.83
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo cortical VOI BMD	1.22 Percent change in BMD	Standard Deviation 4.39
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid vertebra integral VOI BMD	7.33 Percent change in BMD	Standard Deviation 8.67
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Cylinder trabecular VOI BMD	13.29 Percent change in BMD	Standard Deviation 15.32
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Cylinder trabecular VOI BMD	4.88 Percent change in BMD	Standard Deviation 7.68
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra trabecular VOI BMD	4.97 Percent change in BMD	Standard Deviation 6.43
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid vertebra integral VOI BMD	4.85 Percent change in BMD	Standard Deviation 5.25
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo trabecular VOI BMD	5.15 Percent change in BMD	Standard Deviation 6.86
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo cortical VOI BMD	4.98 Percent change in BMD	Standard Deviation 4.63
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra integral VOI BMD	5.04 Percent change in BMD	Standard Deviation 4.39
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra trabecular VOI BMD	23.82 Percent change in BMD	Standard Deviation 14.64
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo cortical VOI BMD	9.25 Percent change in BMD	Standard Deviation 7.68
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid vertebra integral VOI BMD	17.97 Percent change in BMD	Standard Deviation 11.27
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Cylinder trabecular VOI BMD	24.37 Percent change in BMD	Standard Deviation 15.92
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Mid Osteo trabecular VOI BMD	24.21 Percent change in BMD	Standard Deviation 15.8
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans	Total vertebra integral VOI BMD	14.80 Percent change in BMD	Standard Deviation 8.69

Secondary

Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans

QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in mg/cm\^3 in contrast to DXA Which determines an areal density measured in g/cm\^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%.

Time frame: Baseline (Day 0) and Month 12

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter trabecular VOI BMD	-1.62 Percent change in BMD	Standard Deviation 9.67
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur trabecular VOI BMD	-0.36 Percent change in BMD	Standard Deviation 5.53
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck cortical VOI BMD	1.23 Percent change in BMD	Standard Deviation 4.55
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter cortical VOI BMD	0.56 Percent change in BMD	Standard Deviation 5.29
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur cortical VOI BMD	1.11 Percent change in BMD	Standard Deviation 4.04
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter integral VOI BMD	-0.58 Percent change in BMD	Standard Deviation 3.88
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck integral VOI BMD	-0.10 Percent change in BMD	Standard Deviation 2.48
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur integral VOI BMD	0.02 Percent change in BMD	Standard Deviation 2.78
Placebo	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck trabecular VOI BMD	-0.95 Percent change in BMD	Standard Deviation 7.44
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter integral VOI BMD	-0.16 Percent change in BMD	Standard Deviation 4.22
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck trabecular VOI BMD	-2.19 Percent change in BMD	Standard Deviation 7.91
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur cortical VOI BMD	-0.32 Percent change in BMD	Standard Deviation 2.9
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck integral VOI BMD	0.16 Percent change in BMD	Standard Deviation 2.83
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur integral VOI BMD	-0.05 Percent change in BMD	Standard Deviation 2.67
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur trabecular VOI BMD	-0.40 Percent change in BMD	Standard Deviation 6.81
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter trabecular VOI BMD	-1.34 Percent change in BMD	Standard Deviation 13.5
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck cortical VOI BMD	0.44 Percent change in BMD	Standard Deviation 4.16
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter cortical VOI BMD	-0.70 Percent change in BMD	Standard Deviation 4.08
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck cortical VOI BMD	-1.67 Percent change in BMD	Standard Deviation 3.95
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter integral VOI BMD	-1.53 Percent change in BMD	Standard Deviation 3.92
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur integral VOI BMD	-0.81 Percent change in BMD	Standard Deviation 2.8
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck integral VOI BMD	-0.94 Percent change in BMD	Standard Deviation 3.34
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur cortical VOI BMD	-1.46 Percent change in BMD	Standard Deviation 2.81
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter cortical VOI BMD	-1.53 Percent change in BMD	Standard Deviation 3.6
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck trabecular VOI BMD	-2.68 Percent change in BMD	Standard Deviation 6.14
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter trabecular VOI BMD	-2.54 Percent change in BMD	Standard Deviation 11.05
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur trabecular VOI BMD	-2.16 Percent change in BMD	Standard Deviation 7.39
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter trabecular VOI BMD	2.12 Percent change in BMD	Standard Deviation 8.82
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter cortical VOI BMD	-1.48 Percent change in BMD	Standard Deviation 3.53
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur cortical VOI BMD	-1.06 Percent change in BMD	Standard Deviation 2.53
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur trabecular VOI BMD	1.16 Percent change in BMD	Standard Deviation 5.06
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur integral VOI BMD	-0.53 Percent change in BMD	Standard Deviation 2.18
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck cortical VOI BMD	-1.85 Percent change in BMD	Standard Deviation 3.89
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck integral VOI BMD	-1.20 Percent change in BMD	Standard Deviation 2.99
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck trabecular VOI BMD	1.35 Percent change in BMD	Standard Deviation 9.91
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter integral VOI BMD	-1.16 Percent change in BMD	Standard Deviation 3.29
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck integral VOI BMD	-1.45 Percent change in BMD	Standard Deviation 3.22
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur integral VOI BMD	-0.15 Percent change in BMD	Standard Deviation 2.98
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur trabecular VOI BMD	2.81 Percent change in BMD	Standard Deviation 8.2
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur cortical VOI BMD	-1.79 Percent change in BMD	Standard Deviation 3.01
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck trabecular VOI BMD	3.05 Percent change in BMD	Standard Deviation 11.18
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck cortical VOI BMD	-2.80 Percent change in BMD	Standard Deviation 4.55
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter integral VOI BMD	-0.98 Percent change in BMD	Standard Deviation 3.83
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter trabecular VOI BMD	2.10 Percent change in BMD	Standard Deviation 10.66
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter cortical VOI BMD	-2.59 Percent change in BMD	Standard Deviation 4.04
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck trabecular VOI BMD	2.77 Percent change in BMD	Standard Deviation 7.55
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter integral VOI BMD	3.15 Percent change in BMD	Standard Deviation 3.27
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck integral VOI BMD	1.65 Percent change in BMD	Standard Deviation 2.72
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur cortical VOI BMD	2.44 Percent change in BMD	Standard Deviation 3.13
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter cortical VOI BMD	3.33 Percent change in BMD	Standard Deviation 3.57
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter trabecular VOI BMD	3.55 Percent change in BMD	Standard Deviation 7.55
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur trabecular VOI BMD	3.05 Percent change in BMD	Standard Deviation 5.92
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur integral VOI BMD	2.70 Percent change in BMD	Standard Deviation 2.13
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck cortical VOI BMD	1.10 Percent change in BMD	Standard Deviation 4.25
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck trabecular VOI BMD	11.27 Percent change in BMD	Standard Deviation 10.31
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter cortical VOI BMD	1.99 Percent change in BMD	Standard Deviation 4.37
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter trabecular VOI BMD	14.12 Percent change in BMD	Standard Deviation 14.51
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Trochanter integral VOI BMD	4.96 Percent change in BMD	Standard Deviation 4.74
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck integral VOI BMD	2.06 Percent change in BMD	Standard Deviation 3.65
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur trabecular VOI BMD	13.19 Percent change in BMD	Standard Deviation 8.96
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur cortical VOI BMD	0.22 Percent change in BMD	Standard Deviation 2.63
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Neck cortical VOI BMD	-0.69 Percent change in BMD	Standard Deviation 4.49
Teriparatide, 20 mcg, SC Injection, OD	Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans	Femur integral VOI BMD	3.92 Percent change in BMD	Standard Deviation 2.67

Secondary

Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)

DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from baseline to month 6 in aBMD was reported.

Time frame: Baseline (Day 0) and Month 6

Population: Intent to Treat Population. Only those participants available at the specified time point were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)	0.66 percent change in BMD	Standard Error 0.33
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)	0.21 percent change in BMD	Standard Error 0.34
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)	1.61 percent change in BMD	Standard Error 0.35
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)	0.47 percent change in BMD	Standard Error 0.34
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)	1.01 percent change in BMD	Standard Error 0.35
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)	3.42 percent change in BMD	Standard Error 0.34

p-value: 0.6895% CI: [-1.38, 0.48]ANOVA

p-value: 0.19295% CI: [0.01, 1.89]ANOVA

p-value: 0.6895% CI: [-1.12, 0.73]ANOVA

p-value: 0.6895% CI: [-0.59, 1.29]ANOVA

Secondary

Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).

DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from baseline to month 6 and 12 in aBMD of hip (total hip, femoral neck and trochanter) were reported.

Time frame: Baseline (Day 0), Month 6 and Month 12

Population: Intent-to-Treat population. Only those participants available at the specified time points were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 6	0.42 Percent change in BMD	Standard Error 0.23
Placebo	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 12	0.27 Percent change in BMD	Standard Error 0.26
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 6	-0.26 Percent change in BMD	Standard Error 0.24
Ronacaleret, 100 mg Tablet, OD	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 12	-0.62 Percent change in BMD	Standard Error 0.26
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 6	-0.37 Percent change in BMD	Standard Error 0.24
Ronacaleret, 200 mg Tablet, OD	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 12	-0.75 Percent change in BMD	Standard Error 0.27
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 6	-0.86 Percent change in BMD	Standard Error 0.23
Ronacaleret, 300 mg Tablet, OD	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 12	-1.07 Percent change in BMD	Standard Error 0.26
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 6	-0.88 Percent change in BMD	Standard Error 0.24
Ronacaleret, 400 mg Tablet, OD	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 12	-1.31 Percent change in BMD	Standard Error 0.27
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 6	1.84 Percent change in BMD	Standard Error 0.24
Alendronate, 70 mg, Capsule, OW	Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).	Total Hip aBMD, Month 12	2.70 Percent change in BMD	Standard Error 0.27

Comparison: Total Hip aBMD, Month 6p-value: 0.03795% CI: [-1.32, -0.04]ANOVA

Comparison: Total Hip aBMD, Month 6p-value: 0.01795% CI: [-1.43, -0.14]ANOVA

Comparison: Total Hip aBMD, Month 6p-value: 095% CI: [-1.92, -0.64]ANOVA

Comparison: Total Hip aBMD, Month 6p-value: 095% CI: [-1.95, -0.65]ANOVA

Comparison: Total Hip aBMD, Month 12p-value: 0.01595% CI: [-1.61, -0.17]ANOVA

Comparison: Total Hip aBMD, Month 12p-value: 0.00695% CI: [-1.74, -0.3]ANOVA

Comparison: Total Hip aBMD, Month 12p-value: 095% CI: [-2.04, -0.63]ANOVA

Comparison: Total Hip aBMD, Month 12p-value: 095% CI: [-2.3, -0.84]ANOVA

Secondary

Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)

Time frame: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

Population: Pharmacokinetic parameters population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEDIAN)
Placebo	Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Tmax, Month 6	1.483 h
Placebo	Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Tmax, Month 12	1.000 h
Ronacaleret, 100 mg Tablet, OD	Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Tmax, Month 12	1.500 h
Ronacaleret, 100 mg Tablet, OD	Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Tmax, Month 6	1.250 h
Ronacaleret, 200 mg Tablet, OD	Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Tmax, Month 6	1.700 h
Ronacaleret, 200 mg Tablet, OD	Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Tmax, Month 12	1.500 h
Ronacaleret, 300 mg Tablet, OD	Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Tmax, Month 6	1.500 h
Ronacaleret, 300 mg Tablet, OD	Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)	Tmax, Month 12	1.500 h

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Mean Change From Baseline in Height

Mean Change From Baseline in Weight

Number of Participants Withdrew Due to Hypercalcemia

Number of Participants With Hypercalcemia

Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event

Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit

Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit

Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)

Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret

Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)

Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)

Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)

Blood Concentrations of Ronacaleret

Maximum Blood Concentration (Cmax) of Ronacaleret

Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)

Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans

Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans

Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans

Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans

Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)

Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).

Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)