Osteoporosis
Conditions
Keywords
Age Related Osteoporosis, Senile Osteoporosis
Brief summary
The primary purpose of this study is to help answer the following research questions: 1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are). 2. The safety of the teriparatide skin patch and any side effects that might be associated with it.
Detailed description
Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies.
Interventions
DRUGSubcutaneous Teriparatide
Administered subcutaneously once daily for 12 months
DRUGTransdermal Teriparatide
Administered transdermally, applied once daily for 6 hours over 12 months
Sponsors
TransPharma Medical
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory, postmenopausal women. * Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.5. * Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study. * Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver. * Able to be reached by telephone for follow-up contact between visits
Exclusion criteria
* Abnormal laboratory values for albumin and alkaline phosphatase. * Laboratory values outside the ranges defined in the protocol for the following: Serum calcium, intact parathyroid hormone (iPTH), 25 hydroxyvitamin D, and 24-hour urine calcium * History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption. * History of malignant neoplasms in the 5 years prior to randomization, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized. * Use of a pacemaker. * Known chronic dermatological disorder, such as contact dermatitis * History of allergy or sensitivity to tapes or adhesives * Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia. * Patients who have an increased baseline risk of osteosarcoma, Paget's disease of the bone, or unexplained elevations of alkaline phosphatase; or prior external beam, implant radiation therapy involving the skeleton, or previous primary skeletal malignancy. * Major fracture within the past year in the femur, tibia, humerus, or radius (with or without ulna). Treatment with: * calcitonins in the 2 months prior to randomization. * oral, transdermal/patch, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists, selective estrogen receptor modulators, or tibolone in the 3 months prior to randomization; treatment with intravaginal estrogens in doses higher than 0.3 mg of conjugated equine estrogen, or the equivalent, for more than 3 doses per week in the 3 months prior to randomization. * androgens or other anabolic steroids in the 6 months prior to randomization. * fluorides in the 2 years prior to randomization. (Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.) * oral bisphosphonates for more than 2 consecutive months in the 6 months prior to randomization; treatment with intravenous bisphosphonates in the 6 months prior to randomization; treatment with more than 1 cycle of intermittent oral bisphosphonates in the 6 months prior to randomization; or having received the last cycle of this intermittent oral regimen less than 4 weeks prior to screening. * patients receiving intravenous zoledronic acid during the 12 months prior to randomization. * vitamin D greater than 50,000 International Units (IU) per week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to randomization. * systemic corticosteroids in the 1 month prior to randomization or for more than 30 days in the 1 year prior to randomization. (Ophthalmic, otic, topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.) * any other drug known to significantly affect bone metabolism in the 6 months prior to randomization. * warfarin or other coumadin anticoagulants in the 1 month prior to randomization. * any investigational drug in the 1 month prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | Baseline, 12 Months | Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Course Change of BMD Response at the Lumbar Spine | Baseline to 6 Months and 12 Months | To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). |
| Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation. |
| Percent Change From Baseline of C-Terminal Telopeptide (CTX) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | C-terminal telopeptide is a marker of bone resorption. |
| Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | Baseline, 1 Month | Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation. |
| Convenience/Ease of Use Questionnaire (CEUQ) | baseline up to 12 months | CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument. |
| Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline, 12 Months | Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + \[(40 - albumin) x 0.02\]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon). |
| Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | Baseline, 6 Months, 12 Months | — |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | Baseline, 6 Months | Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects. |
| Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months | — |
| Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline and 1, 3, 12, and 13 Months (mon) | Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8). |
| Pharmacokinetics Parameters: Area Under the Curve (AUC) | Baseline, 1 Month, 3 Months, and 12 Months | Due to high intra-subject variability, data was not analyzed for this outcome measure. |
| Pharmacokinetics Parameters: Maximal Concentration (Cmax) | Baseline, 1 Month, 3 Months, 12 Months | Due to high intra-subject variability, data was not analyzed for this outcome measure. |
| DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 13 Month follow-up | Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure) |
| DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 13 Month follow-up | Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar) |
| Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position. |
Countries
Argentina, Estonia, Hungary, Mexico, Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 20 Mcg Subcutaneous Teriparatide Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner. | 57 |
| 30 Mcg Transdermal Teriparatide Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. | 56 |
| 50 Mcg Transdermal Teriparatide Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. | 54 |
| 80 Mcg Transdermal Teriparatide Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. | 64 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 2 | 1 |
| Overall Study | Inclusion/exclusion criteria not met | 2 | 1 | 3 | 5 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Sponsor decision | 0 | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 4 | 4 |
Baseline characteristics
| Characteristic | 20 Mcg Subcutaneous Teriparatide | Total | 80 Mcg Transdermal Teriparatide | 50 Mcg Transdermal Teriparatide | 30 Mcg Transdermal Teriparatide |
|---|---|---|---|---|---|
| Age Continuous | 63.9 years STANDARD_DEVIATION 7.2 | 65.4 years STANDARD_DEVIATION 7.8 | 65.1 years STANDARD_DEVIATION 7.2 | 67.6 years STANDARD_DEVIATION 8.4 | 65.0 years STANDARD_DEVIATION 8.3 |
| Race/Ethnicity, Customized Hispanic or Latino | 14 participants | 60 participants | 17 participants | 14 participants | 15 participants |
| Race/Ethnicity, Customized Latin American | 0 participants | 3 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Mexican | 7 participants | 24 participants | 6 participants | 5 participants | 6 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 33 participants | 137 participants | 40 participants | 32 participants | 32 participants |
| Race/Ethnicity, Customized South American | 1 participants | 3 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Spaniard | 2 participants | 4 participants | 1 participants | 1 participants | 0 participants |
| Region of Enrollment Argentina | 17 participants | 68 participants | 18 participants | 16 participants | 17 participants |
| Region of Enrollment Estonia | 4 participants | 15 participants | 4 participants | 6 participants | 1 participants |
| Region of Enrollment Hungary | 21 participants | 94 participants | 25 participants | 23 participants | 25 participants |
| Region of Enrollment Mexico | 7 participants | 24 participants | 6 participants | 5 participants | 6 participants |
| Region of Enrollment Romania | 8 participants | 30 participants | 11 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 57 Participants | 231 Participants | 64 Participants | 54 Participants | 56 Participants |
| Sex: Female, Male Male | 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 |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 57 | 33 / 56 | 30 / 54 | 39 / 64 |
| serious Total, serious adverse events | 2 / 57 | 2 / 56 | 1 / 54 | 5 / 64 |
Outcome results
Primary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
Time frame: Baseline, 12 Months
Population: All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | 7.80 percentage change in BMD |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | 0.63 percentage change in BMD |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | 0.32 percentage change in BMD |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | 1.63 percentage change in BMD |
p-value: <0.00190% CI: [-8.489, -5.851]ANCOVA
p-value: <0.00190% CI: [-8.822, -6.144]ANCOVA
p-value: <0.00190% CI: [-7.448, -4.891]ANCOVA
Secondary
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
Time frame: Baseline, 6 Months, 12 Months
Population: All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 12 months (n=51, 47, 41, 51) | 5.25 millimole/day (mmol/day) | Standard Deviation 3.694 |
| 20 Mcg Subcutaneous Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | Baseline | 4.45 millimole/day (mmol/day) | Standard Deviation 1.851 |
| 20 Mcg Subcutaneous Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 6 months (n=54, 50, 49, 56) | 2.02 millimole/day (mmol/day) | Standard Deviation 4.122 |
| 30 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 6 months (n=54, 50, 49, 56) | 0.70 millimole/day (mmol/day) | Standard Deviation 3.467 |
| 30 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | Baseline | 4.21 millimole/day (mmol/day) | Standard Deviation 1.766 |
| 30 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 12 months (n=51, 47, 41, 51) | 4.97 millimole/day (mmol/day) | Standard Deviation 2.192 |
| 50 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 12 months (n=51, 47, 41, 51) | 4.80 millimole/day (mmol/day) | Standard Deviation 2.738 |
| 50 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | Baseline | 4.26 millimole/day (mmol/day) | Standard Deviation 1.673 |
| 50 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 6 months (n=54, 50, 49, 56) | 1.20 millimole/day (mmol/day) | Standard Deviation 2.768 |
| 80 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 6 months (n=54, 50, 49, 56) | 1.35 millimole/day (mmol/day) | Standard Deviation 2.36 |
| 80 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | Baseline | 4.24 millimole/day (mmol/day) | Standard Deviation 1.876 |
| 80 Mcg Transdermal Teriparatide | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 12 months (n=51, 47, 41, 51) | 4.51 millimole/day (mmol/day) | Standard Deviation 2.77 |
Secondary
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.
Time frame: Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months
Population: All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, SBP, 30min (n=51,47,44,51) | 0.8 mmHg | Standard Deviation 8.52 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, SBP, 2 h (n=56,56,53,63) | -0.3 mmHg | Standard Deviation 13.06 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, DBP, 30 min (n=56,54,51,62) | -1.9 mmHg | Standard Deviation 7.63 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, DBP, 2 h (n=56,56,53,63) | -2.1 mmHg | Standard Deviation 7.59 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, SBP, 30 min (n=56,54,51,62) | -0.6 mmHg | Standard Deviation 10.71 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, SBP, 2 h (n=51,47,44,51) | -0.2 mmHg | Standard Deviation 10.71 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, DBP, 30min (n=52,48,45,51) | -1.8 mmHg | Standard Deviation 7.14 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, DBP, 2 h (n=51,47,44,51) | -1.3 mmHg | Standard Deviation 6.94 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, SBP, 30 min (n=56,54,51,62) | -1.3 mmHg | Standard Deviation 9.38 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, SBP, 2 h (n=56,56,53,64) | -1.7 mmHg | Standard Deviation 11.57 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, DBP, 30 min (n=56,54,51,62) | -2.3 mmHg | Standard Deviation 6.56 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, DBP, 2 h (n=56,56,53,64) | -2.3 mmHg | Standard Deviation 7.55 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, SBP, 30min(n=51,47,44,51) | -0.6 mmHg | Standard Deviation 10.55 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, SBP, 2 h (n=51,47,44,51) | -0.1 mmHg | Standard Deviation 11.86 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, DBP, 30 min(n=51,47,44,51 | -1.8 mmHg | Standard Deviation 7.12 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, DBP, 2 h (n=51,47,44,51) | 1.1 mmHg | Standard Deviation 6.93 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, SBP, 2 h (n=51,47,44,51) | -1.8 mmHg | Standard Deviation 11.19 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, SBP, 30 min (n=56,54,51,62) | 2.5 mmHg | Standard Deviation 8.93 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, DBP, 2 h (n=51,47,44,51) | -2.0 mmHg | Standard Deviation 7.35 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, DBP, 2 h (n=56,56,53,64) | -2.1 mmHg | Standard Deviation 7.8 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, DBP, 30 min(n=51,47,44,51 | -2.4 mmHg | Standard Deviation 6.04 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, SBP, 2 h (n=56,56,53,64) | -1.6 mmHg | Standard Deviation 11.03 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, DBP, 30 min (n=56,54,51,62) | 1.4 mmHg | Standard Deviation 7.59 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, DBP, 30 min (n=56,54,51,62) | 0.2 mmHg | Standard Deviation 8.18 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, SBP, 30min (n=51,47,44,51) | -2.2 mmHg | Standard Deviation 7.47 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, DBP, 30min (n=52,48,45,51) | -1.8 mmHg | Standard Deviation 6.08 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, DBP, 2 h (n=56,56,53,63) | -0.8 mmHg | Standard Deviation 8.51 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, SBP, 2 h (n=56,56,53,63) | -0.9 mmHg | Standard Deviation 10.97 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, SBP, 30min(n=51,47,44,51) | -0.9 mmHg | Standard Deviation 8.41 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, DBP, 2 h (n=51,47,44,51) | -3.3 mmHg | Standard Deviation 7.79 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, SBP, 2 h (n=51,47,44,51) | -0.4 mmHg | Standard Deviation 7.64 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, SBP, 30 min (n=56,54,51,62) | 2.0 mmHg | Standard Deviation 10.25 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, SBP, 2 h (n=51,47,44,51) | -2.5 mmHg | Standard Deviation 9.54 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, SBP, 30min (n=51,47,44,51) | -1.1 mmHg | Standard Deviation 8.87 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, SBP, 2 h (n=51,47,44,51) | -1.3 mmHg | Standard Deviation 12.97 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, DBP, 30min (n=52,48,45,51) | -2.1 mmHg | Standard Deviation 6.77 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, DBP, 2 h (n=51,47,44,51) | -1.3 mmHg | Standard Deviation 6.79 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, DBP, 2 h (n=51,47,44,51) | -1.9 mmHg | Standard Deviation 7.7 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, SBP, 30 min (n=56,54,51,62) | -0.6 mmHg | Standard Deviation 10.65 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, SBP, 2 h (n=56,56,53,64) | -3.8 mmHg | Standard Deviation 10.96 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, DBP, 30 min(n=51,47,44,51 | -3.5 mmHg | Standard Deviation 8.09 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, DBP, 30 min (n=56,54,51,62) | -1.2 mmHg | Standard Deviation 8.34 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, DBP, 2 h (n=56,56,53,64) | -1.1 mmHg | Standard Deviation 7.25 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, SBP, 30 min (n=56,54,51,62) | -1.0 mmHg | Standard Deviation 11.59 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, SBP, 2 h (n=56,56,53,63) | -3.5 mmHg | Standard Deviation 9.97 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, SBP, 30min(n=51,47,44,51) | 0.5 mmHg | Standard Deviation 8.68 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, DBP, 30 min (n=56,54,51,62) | -2.5 mmHg | Standard Deviation 7.5 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, DBP, 2 h (n=56,56,53,63) | -3.6 mmHg | Standard Deviation 7.02 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, DBP, 2 h (n=51,47,44,51) | 0.1 mmHg | Standard Deviation 7.44 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, DBP, 2 h (n=51,47,44,51) | -2.0 mmHg | Standard Deviation 8.59 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, DBP, 30 min (n=56,54,51,62) | -1.1 mmHg | Standard Deviation 7.17 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, SBP, 30 min (n=56,54,51,62) | -0.8 mmHg | Standard Deviation 10.77 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, SBP, 2 h (n=51,47,44,51) | -0.9 mmHg | Standard Deviation 10.24 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, DBP, 30min (n=52,48,45,51) | -1.2 mmHg | Standard Deviation 7.25 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, SBP, 30min(n=51,47,44,51) | -0.8 mmHg | Standard Deviation 8.72 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, SBP, 2 h (n=56,56,53,63) | -0.6 mmHg | Standard Deviation 12.91 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, SBP, 30min (n=51,47,44,51) | -2.0 mmHg | Standard Deviation 9.82 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, SBP, 2 h (n=56,56,53,64) | 0.0 mmHg | Standard Deviation 12.11 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, supine, SBP, 2 h (n=51,47,44,51) | -1.9 mmHg | Standard Deviation 10.87 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, DBP, 30 min (n=56,54,51,62) | -1.2 mmHg | Standard Deviation 7.8 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | 12mon, standing, DBP, 30 min(n=51,47,44,51 | 1.4 mmHg | Standard Deviation 7.75 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, SBP, 30 min (n=56,54,51,62) | -0.5 mmHg | Standard Deviation 10.04 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, supine, DBP, 2 h (n=56,56,53,63) | -1.6 mmHg | Standard Deviation 7.67 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | BL, standing, DBP, 2 h (n=56,56,53,64) | -1.7 mmHg | Standard Deviation 8.84 |
Secondary
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
Time frame: Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months
Population: All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, supine, 30 min (n=56,54,51,62) | 1.8 beats per minute (bpm) | Standard Deviation 5.66 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, supine, 2 h (n=56,56,53,63) | 1.5 beats per minute (bpm) | Standard Deviation 8.01 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, standing, 30 min (n=56,54,51,62) | 1.6 beats per minute (bpm) | Standard Deviation 6.41 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, standing, 2 h (n=56,56,53,64) | 1.0 beats per minute (bpm) | Standard Deviation 8.03 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, supine, 30 min (n=51,47,44,51) | 2.5 beats per minute (bpm) | Standard Deviation 4.81 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, supine, 2 h (n=51,47,44,51) | 1.6 beats per minute (bpm) | Standard Deviation 6.74 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, standing, 30 min (n=51,47,44,51) | 1.2 beats per minute (bpm) | Standard Deviation 7.35 |
| 20 Mcg Subcutaneous Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, standing, 2 h (n=51,47,44,51) | 0.9 beats per minute (bpm) | Standard Deviation 9.03 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, supine, 2 h (n=51,47,44,51) | 1.1 beats per minute (bpm) | Standard Deviation 6.6 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, supine, 30 min (n=51,47,44,51) | 1.4 beats per minute (bpm) | Standard Deviation 4.74 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, supine, 2 h (n=56,56,53,63) | 0.9 beats per minute (bpm) | Standard Deviation 5.61 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, standing, 2 h (n=51,47,44,51) | 0.1 beats per minute (bpm) | Standard Deviation 7.36 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, standing, 30 min (n=51,47,44,51) | 0.0 beats per minute (bpm) | Standard Deviation 5.28 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, standing, 2 h (n=56,56,53,64) | -0.8 beats per minute (bpm) | Standard Deviation 8.51 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, standing, 30 min (n=56,54,51,62) | -1.0 beats per minute (bpm) | Standard Deviation 7.36 |
| 30 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, supine, 30 min (n=56,54,51,62) | 1.7 beats per minute (bpm) | Standard Deviation 5.96 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, standing, 30 min (n=51,47,44,51) | -0.7 beats per minute (bpm) | Standard Deviation 5.97 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, standing, 30 min (n=56,54,51,62) | 0.7 beats per minute (bpm) | Standard Deviation 6.68 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, standing, 2 h (n=56,56,53,64) | 0.5 beats per minute (bpm) | Standard Deviation 6.51 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, supine, 30 min (n=51,47,44,51) | -0.1 beats per minute (bpm) | Standard Deviation 4.06 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, supine, 2 h (n=51,47,44,51) | -0.3 beats per minute (bpm) | Standard Deviation 5.43 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, standing, 2 h (n=51,47,44,51) | -0.4 beats per minute (bpm) | Standard Deviation 7.03 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, supine, 30 min (n=56,54,51,62) | -0.8 beats per minute (bpm) | Standard Deviation 7.21 |
| 50 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, supine, 2 h (n=56,56,53,63) | -0.8 beats per minute (bpm) | Standard Deviation 8.49 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, standing, 30 min (n=56,54,51,62) | -1.2 beats per minute (bpm) | Standard Deviation 7.61 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, standing, 2 h (n=56,56,53,64) | -1.0 beats per minute (bpm) | Standard Deviation 8.05 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, supine, 2 h (n=56,56,53,63) | -0.4 beats per minute (bpm) | Standard Deviation 6.9 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | BL, supine, 30 min (n=56,54,51,62) | -0.6 beats per minute (bpm) | Standard Deviation 6.5 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, supine, 30 min (n=51,47,44,51) | -0.2 beats per minute (bpm) | Standard Deviation 5.22 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, standing, 2 h (n=51,47,44,51) | -0.7 beats per minute (bpm) | Standard Deviation 7.72 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, standing, 30 min (n=51,47,44,51) | -0.4 beats per minute (bpm) | Standard Deviation 6.9 |
| 80 Mcg Transdermal Teriparatide | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | 12 mon, supine, 2 h (n=51,47,44,51) | -0.8 beats per minute (bpm) | Standard Deviation 6.69 |
Secondary
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + \[(40 - albumin) x 0.02\]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).
Time frame: Baseline, 12 Months
Population: All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon- predose albumin adjusted (n=52,47,45,50) | 2.461 millimole/Liter (mmol/L) | Standard Deviation 0.0998 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-6 h PD; albumin adjusted (n=52,47,45,50) | 2.547 millimole/Liter (mmol/L) | Standard Deviation 0.1236 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-4 h PD; albumin adjusted (n=52,52,50,61) | 2.418 millimole/Liter (mmol/L) | Standard Deviation 0.1099 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- predose; no adjustment (n=54,53,51,62) | 2.391 millimole/Liter (mmol/L) | Standard Deviation 0.0776 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-6 h PD; albumin adjusted (n=49,50,47,57) | 2.423 millimole/Liter (mmol/L) | Standard Deviation 0.11 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- 6 h PD; no adjustment (n=52,51,48,59) | 2.440 millimole/Liter (mmol/L) | Standard Deviation 0.1159 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-predose; no adjustment (n=52,47,45,50) | 2.463 millimole/Liter (mmol/L) | Standard Deviation 0.1243 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- 4 h PD; no adjustment (n=55,53,51,63) | 2.432 millimole/Liter (mmol/L) | Standard Deviation 0.1191 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon- 4 h PD; albumin adjusted (n=51,46,44,51) | 2.523 millimole/Liter (mmol/L) | Standard Deviation 0.168 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-4 h PD; no adjustment (n=51,46,44,51) | 2.516 millimole/Liter (mmol/L) | Standard Deviation 0.1815 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-6 h PD; no adjustment (n=50,45,44,51) | 2.532 millimole/Liter (mmol/L) | Standard Deviation 0.1429 |
| 20 Mcg Subcutaneous Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-predose albumin adjusted (n=53,53,50,60) | 2.363 millimole/Liter (mmol/L) | Standard Deviation 0.0811 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- 4 h PD; no adjustment (n=55,53,51,63) | 2.358 millimole/Liter (mmol/L) | Standard Deviation 0.1315 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-predose albumin adjusted (n=53,53,50,60) | 2.341 millimole/Liter (mmol/L) | Standard Deviation 0.0949 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-predose; no adjustment (n=52,47,45,50) | 2.427 millimole/Liter (mmol/L) | Standard Deviation 0.0977 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-6 h PD; albumin adjusted (n=49,50,47,57) | 2.363 millimole/Liter (mmol/L) | Standard Deviation 0.0727 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon- predose albumin adjusted (n=52,47,45,50) | 2.432 millimole/Liter (mmol/L) | Standard Deviation 0.0806 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-4 h PD; albumin adjusted (n=52,52,50,61) | 2.348 millimole/Liter (mmol/L) | Standard Deviation 0.1283 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- predose; no adjustment (n=54,53,51,62) | 2.362 millimole/Liter (mmol/L) | Standard Deviation 0.0933 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-6 h PD; no adjustment (n=50,45,44,51) | 2.426 millimole/Liter (mmol/L) | Standard Deviation 0.0866 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-4 h PD; no adjustment (n=51,46,44,51) | 2.428 millimole/Liter (mmol/L) | Standard Deviation 0.1024 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- 6 h PD; no adjustment (n=52,51,48,59) | 2.369 millimole/Liter (mmol/L) | Standard Deviation 0.0789 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-6 h PD; albumin adjusted (n=52,47,45,50) | 2.443 millimole/Liter (mmol/L) | Standard Deviation 0.0838 |
| 30 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon- 4 h PD; albumin adjusted (n=51,46,44,51) | 2.438 millimole/Liter (mmol/L) | Standard Deviation 0.1022 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-4 h PD; albumin adjusted (n=52,52,50,61) | 2.403 millimole/Liter (mmol/L) | Standard Deviation 0.0928 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- predose; no adjustment (n=54,53,51,62) | 2.389 millimole/Liter (mmol/L) | Standard Deviation 0.0921 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- 4 h PD; no adjustment (n=55,53,51,63) | 2.403 millimole/Liter (mmol/L) | Standard Deviation 0.116 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- 6 h PD; no adjustment (n=52,51,48,59) | 2.400 millimole/Liter (mmol/L) | Standard Deviation 0.1167 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-predose; no adjustment (n=52,47,45,50) | 2.427 millimole/Liter (mmol/L) | Standard Deviation 0.0842 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-4 h PD; no adjustment (n=51,46,44,51) | 2.430 millimole/Liter (mmol/L) | Standard Deviation 0.1199 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-6 h PD; no adjustment (n=50,45,44,51) | 2.443 millimole/Liter (mmol/L) | Standard Deviation 0.0997 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-predose albumin adjusted (n=53,53,50,60) | 2.376 millimole/Liter (mmol/L) | Standard Deviation 0.0807 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-6 h PD; albumin adjusted (n=49,50,47,57) | 2.404 millimole/Liter (mmol/L) | Standard Deviation 0.0908 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon- predose albumin adjusted (n=52,47,45,50) | 2.449 millimole/Liter (mmol/L) | Standard Deviation 0.0861 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon- 4 h PD; albumin adjusted (n=51,46,44,51) | 2.458 millimole/Liter (mmol/L) | Standard Deviation 0.1012 |
| 50 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-6 h PD; albumin adjusted (n=52,47,45,50) | 2.481 millimole/Liter (mmol/L) | Standard Deviation 0.1044 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-6 h PD; no adjustment (n=50,45,44,51) | 2.467 millimole/Liter (mmol/L) | Standard Deviation 0.0959 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-4 h PD; no adjustment (n=51,46,44,51) | 2.464 millimole/Liter (mmol/L) | Standard Deviation 0.1042 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- predose; no adjustment (n=54,53,51,62) | 2.392 millimole/Liter (mmol/L) | Standard Deviation 0.0915 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon- predose albumin adjusted (n=52,47,45,50) | 2.442 millimole/Liter (mmol/L) | Standard Deviation 0.084 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-predose; no adjustment (n=52,47,45,50) | 2.432 millimole/Liter (mmol/L) | Standard Deviation 0.0937 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- 6 h PD; no adjustment (n=52,51,48,59) | 2.397 millimole/Liter (mmol/L) | Standard Deviation 0.1048 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon-6 h PD; albumin adjusted (n=52,47,45,50) | 2.483 millimole/Liter (mmol/L) | Standard Deviation 0.1348 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | 12 mon- 4 h PD; albumin adjusted (n=51,46,44,51) | 2.482 millimole/Liter (mmol/L) | Standard Deviation 0.0962 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-4 h PD; albumin adjusted (n=52,52,50,61) | 2.386 millimole/Liter (mmol/L) | Standard Deviation 0.1045 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-predose albumin adjusted (n=53,53,50,60) | 2.373 millimole/Liter (mmol/L) | Standard Deviation 0.0809 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline- 4 h PD; no adjustment (n=55,53,51,63) | 2.393 millimole/Liter (mmol/L) | Standard Deviation 0.1113 |
| 80 Mcg Transdermal Teriparatide | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | baseline-6 h PD; albumin adjusted (n=49,50,47,57) | 2.394 millimole/Liter (mmol/L) | Standard Deviation 0.0934 |
Secondary
Convenience/Ease of Use Questionnaire (CEUQ)
CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.
Time frame: baseline up to 12 months
Population: All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Neutral | 1 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Not Confident | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Somewhat Disagree | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Somewhat Fearful | 1 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Somewhat Not Confident | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Neutral | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Extremely Fearful | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Somewhat Confident | 13 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Very Confident | 42 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Neutral | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Somewhat Dissatisfied | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Somewhat Agree | 11 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Very Dissatisfied | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Strongly Agree | 44 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Somewhat Satisfied | 10 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Strongly Disagree | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Neutral | 1 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Not Fearful | 44 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Somewhat Disagree | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Stronly Disagree | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Neutral | 1 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Somewhat Not Fearful | 9 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Somewhat Agree | 11 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Very Satisfied | 44 participants |
| 20 Mcg Subcutaneous Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Strongly Agree | 43 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Somewhat Agree | 12 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Somewhat Not Fearful | 16 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Not Confident | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Strongly Agree | 41 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Strongly Agree | 45 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Neutral | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Somewhat Not Confident | 1 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Somewhat Disagree | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Extremely Fearful | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Not Fearful | 37 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Neutral | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Very Satisfied | 40 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Neutral | 1 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Strongly Disagree | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Somewhat Confident | 15 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Somewhat Dissatisfied | 1 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Very Confident | 38 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Stronly Disagree | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Neutral | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Neutral | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Somewhat Satisfied | 13 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Somewhat Fearful | 1 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Somewhat Disagree | 0 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Somewhat Agree | 9 participants |
| 30 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Very Dissatisfied | 0 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Somewhat Agree | 8 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Somewhat Satisfied | 10 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Very Satisfied | 38 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Somewhat Fearful | 0 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Stronly Disagree | 0 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Somewhat Disagree | 0 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Neutral | 1 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Somewhat Dissatisfied | 1 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Strongly Agree | 42 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Strongly Disagree | 0 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Somewhat Disagree | 0 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Neutral | 1 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Somewhat Agree | 9 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Strongly Agree | 41 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Not Confident | 1 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Somewhat Not Confident | 0 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Neutral | 3 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Somewhat Confident | 11 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Very Confident | 36 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Extremely Fearful | 1 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Neutral | 1 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Somewhat Not Fearful | 9 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Not Fearful | 40 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Very Dissatisfied | 0 participants |
| 50 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Neutral | 2 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Not Confident | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Strongly Agree | 50 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Somewhat Agree | 12 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Stronly Disagree | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Neutral | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Neutral | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Somewhat Disagree | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Somewhat Fearful | 1 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Somewhat Not Fearful | 13 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S2-Strongly Disagree | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Strongly Agree | 52 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Somewhat Satisfied | 18 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Not Fearful | 48 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Somewhat Agree | 10 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Very Satisfied | 43 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Neutral | 1 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Very Dissatisfied | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Neutral | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Somewhat Confident | 17 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S1-Somewhat Disagree | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Very Confident | 40 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Neutral | 4 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S3-Somewhat Not Confident | 1 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S5-Somewhat Dissatisfied | 0 participants |
| 80 Mcg Transdermal Teriparatide | Convenience/Ease of Use Questionnaire (CEUQ) | S4-Extremely Fearful | 0 participants |
Secondary
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)
Time frame: 13 Month follow-up
Population: All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 1=very slight edema to 4=severe edema | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 0=no edema | 41 participants |
| 30 Mcg Transdermal Teriparatide | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 0=no edema | 39 participants |
| 30 Mcg Transdermal Teriparatide | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 1=very slight edema to 4=severe edema | 0 participants |
| 50 Mcg Transdermal Teriparatide | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 0=no edema | 39 participants |
| 50 Mcg Transdermal Teriparatide | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 1=very slight edema to 4=severe edema | 0 participants |
| 80 Mcg Transdermal Teriparatide | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 1=very slight edema to 4=severe edema | 0 participants |
| 80 Mcg Transdermal Teriparatide | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 0=no edema | 43 participants |
Secondary
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)
Time frame: 13 Month follow-up
Population: All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 0=no erythema | 41 participants |
| 20 Mcg Subcutaneous Teriparatide | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 1=very slight erythema to 4=severe erythema | 0 participants |
| 30 Mcg Transdermal Teriparatide | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 1=very slight erythema to 4=severe erythema | 0 participants |
| 30 Mcg Transdermal Teriparatide | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 0=no erythema | 39 participants |
| 50 Mcg Transdermal Teriparatide | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 0=no erythema | 39 participants |
| 50 Mcg Transdermal Teriparatide | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 1=very slight erythema to 4=severe erythema | 0 participants |
| 80 Mcg Transdermal Teriparatide | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 0=no erythema | 43 participants |
| 80 Mcg Transdermal Teriparatide | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 1=very slight erythema to 4=severe erythema | 0 participants |
Secondary
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).
Time frame: Baseline and 1, 3, 12, and 13 Months (mon)
Population: All randomized participants who received at least one dose of study drug and had antibody results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-synthetic titer 1:8 (n=55,52,51,61) | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-synthetic titer 1:8 (n=57,54,53,64) | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-recombinant titer 1:8 (n=54,54,51,62 | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-synthetic ND (n=55,52,51,61) | 55 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-synthetic ND (N=54,54,51,62) | 54 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline: anti-recombinant ND (n=57, 54, 53, 64) | 57 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-synthetic titer 1:8 (N=54,54,51,62) | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-recombinant titer 1:8(n=57,54,53,64) | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-synthetic ND (n=50,46,44,50) | 50 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-recombinant ND (n=55,52,51,61) | 55 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-recombinant titer 1:8 (n=55,52,51,6 | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-synthetic titer 18 (n=52,48,45,51) | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-recombinant ND (n=52,48,45,51) | 52 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-synthetic titer 1:8 (n=50,46,44,50) | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-recombinant titer 1:8 (n=52,48,45,51) | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-recombinant ND (n=54,54,51,62) | 54 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-synthetic ND (n=52,48,45,51) | 52 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-recombinant ND (n=50,46,44,50) | 50 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-recombinant titer 1:8 (n=50,46,44,50) | 0 participants |
| 20 Mcg Subcutaneous Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-synthetic ND (n=57,54,53,64) | 57 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-synthetic titer 1:8 (n=55,52,51,61) | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-synthetic ND (n=57,54,53,64) | 54 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-synthetic ND (n=50,46,44,50) | 46 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-synthetic ND (n=55,52,51,61) | 52 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-recombinant titer 1:8 (n=55,52,51,6 | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-synthetic titer 1:8 (n=57,54,53,64) | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline: anti-recombinant ND (n=57, 54, 53, 64) | 54 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-synthetic titer 1:8 (n=50,46,44,50) | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-recombinant titer 1:8 (n=50,46,44,50) | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-synthetic ND (N=54,54,51,62) | 54 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-recombinant ND (n=52,48,45,51) | 48 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-synthetic titer 1:8 (N=54,54,51,62) | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-recombinant ND (n=50,46,44,50) | 46 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-recombinant titer 1:8 (n=54,54,51,62 | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-synthetic ND (n=52,48,45,51) | 48 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-recombinant ND (n=54,54,51,62) | 54 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-recombinant titer 1:8 (n=52,48,45,51) | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-recombinant ND (n=55,52,51,61) | 52 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-recombinant titer 1:8(n=57,54,53,64) | 0 participants |
| 30 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-synthetic titer 18 (n=52,48,45,51) | 0 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-synthetic ND (N=54,54,51,62) | 50 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline: anti-recombinant ND (n=57, 54, 53, 64) | 52 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-recombinant titer 1:8(n=57,54,53,64) | 1 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-recombinant ND (n=54,54,51,62) | 51 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-recombinant titer 1:8 (n=54,54,51,62 | 0 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-recombinant ND (n=55,52,51,61) | 50 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-recombinant titer 1:8 (n=55,52,51,6 | 1 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-recombinant ND (n=52,48,45,51) | 44 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-recombinant titer 1:8 (n=52,48,45,51) | 1 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-recombinant ND (n=50,46,44,50) | 43 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-recombinant titer 1:8 (n=50,46,44,50) | 1 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-synthetic ND (n=57,54,53,64) | 52 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-synthetic titer 1:8 (n=57,54,53,64) | 1 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-synthetic titer 1:8 (N=54,54,51,62) | 1 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-synthetic ND (n=55,52,51,61) | 50 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-synthetic titer 1:8 (n=55,52,51,61) | 1 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-synthetic ND (n=52,48,45,51) | 44 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-synthetic titer 18 (n=52,48,45,51) | 1 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-synthetic ND (n=50,46,44,50) | 43 participants |
| 50 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-synthetic titer 1:8 (n=50,46,44,50) | 1 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-recombinant titer 1:8 (n=50,46,44,50) | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-recombinant ND (n=50,46,44,50) | 50 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-synthetic ND (n=50,46,44,50) | 50 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-synthetic titer 1:8 (n=55,52,51,61) | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-recombinant titer 1:8 (n=52,48,45,51) | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-recombinant ND (n=52,48,45,51) | 51 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-recombinant titer 1:8(n=57,54,53,64) | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-synthetic ND (n=52,48,45,51) | 51 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-recombinant titer 1:8 (n=55,52,51,6 | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-recombinant ND (n=55,52,51,61) | 61 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline: anti-recombinant ND (n=57, 54, 53, 64) | 64 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 12 mon:anti-synthetic titer 18 (n=52,48,45,51) | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-recombinant titer 1:8 (n=54,54,51,62 | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-synthetic ND (N=54,54,51,62) | 62 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-recombinant ND (n=54,54,51,62) | 62 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 1 mon:anti-synthetic titer 1:8 (N=54,54,51,62) | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-synthetic titer 1:8 (n=57,54,53,64) | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline:anti-synthetic ND (n=57,54,53,64) | 64 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 13 mon:anti-synthetic titer 1:8 (n=50,46,44,50) | 0 participants |
| 80 Mcg Transdermal Teriparatide | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | 3 mon:anti-synthetic ND (n=55,52,51,61) | 61 participants |
Secondary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.
Time frame: Baseline, 6 Months
Population: All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | 4.74 percentage change in BMD |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | 0.16 percentage change in BMD |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | 0.88 percentage change in BMD |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | 1.19 percentage change in BMD |
p-value: <0.00190% CI: [-5.716, -3.452]ANCOVA
p-value: <0.00190% CI: [-5.006, -2.727]ANCOVA
p-value: <0.00190% CI: [-4.652, -2.464]ANCOVA
Secondary
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Population: All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 1 month (n=49, 53, 49, 60) | 112.47 percentage change in P1NP | Standard Deviation 65.39 |
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 3 months (n=50, 51, 49, 59) | 174.88 percentage change in P1NP | Standard Deviation 118.745 |
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 6 months (n=48, 49, 48, 56) | 284.89 percentage change in P1NP | Standard Deviation 228.773 |
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 12 months (n=47, 46, 43, 49) | 232.41 percentage change in P1NP | Standard Deviation 176.557 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 3 months (n=50, 51, 49, 59) | 35.68 percentage change in P1NP | Standard Deviation 50.358 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 6 months (n=48, 49, 48, 56) | 62.99 percentage change in P1NP | Standard Deviation 78.579 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 12 months (n=47, 46, 43, 49) | 72.17 percentage change in P1NP | Standard Deviation 86.747 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 1 month (n=49, 53, 49, 60) | 19.29 percentage change in P1NP | Standard Deviation 35.274 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 6 months (n=48, 49, 48, 56) | 93.82 percentage change in P1NP | Standard Deviation 93.575 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 3 months (n=50, 51, 49, 59) | 53.53 percentage change in P1NP | Standard Deviation 64.625 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 12 months (n=47, 46, 43, 49) | 97.14 percentage change in P1NP | Standard Deviation 98.007 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 1 month (n=49, 53, 49, 60) | 27.78 percentage change in P1NP | Standard Deviation 31.064 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 12 months (n=47, 46, 43, 49) | 178.02 percentage change in P1NP | Standard Deviation 181.361 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 3 months (n=50, 51, 49, 59) | 116.34 percentage change in P1NP | Standard Deviation 117.697 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 1 month (n=49, 53, 49, 60) | 42.06 percentage change in P1NP | Standard Deviation 53 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | 6 months (n=48, 49, 48, 56) | 221.28 percentage change in P1NP | Standard Deviation 233.297 |
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: 0.003Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: 0.029Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: 0.047Wilcoxon Rank Sum Test
Secondary
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Time frame: Baseline, 1 Month
Population: All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | 80.10 percentage change in P1CP | Standard Deviation 85.421 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | 4.63 percentage change in P1CP | Standard Deviation 29.694 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | 12.30 percentage change in P1CP | Standard Deviation 30.153 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | 23.84 percentage change in P1CP | Standard Deviation 44.813 |
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
Secondary
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
C-terminal telopeptide is a marker of bone resorption.
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Population: All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 1 month (n=49, 53, 49, 60) | 20.57 percentage change in CTX | Standard Deviation 64.98 |
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 3 months (n=50, 51, 49, 59) | 87.78 percentage change in CTX | Standard Deviation 96.777 |
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 6 months (n=48, 49, 48, 56) | 123.36 percentage change in CTX | Standard Deviation 128.832 |
| 20 Mcg Subcutaneous Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 12 months (n=47, 46, 43, 49) | 97.52 percentage change in CTX | Standard Deviation 109.981 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 3 months (n=50, 51, 49, 59) | 30.66 percentage change in CTX | Standard Deviation 42.048 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 6 months (n=48, 49, 48, 56) | 37.36 percentage change in CTX | Standard Deviation 52.875 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 12 months (n=47, 46, 43, 49) | 37.75 percentage change in CTX | Standard Deviation 58.035 |
| 30 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 1 month (n=49, 53, 49, 60) | 8.05 percentage change in CTX | Standard Deviation 26.07 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 6 months (n=48, 49, 48, 56) | 68.63 percentage change in CTX | Standard Deviation 71.059 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 3 months (n=50, 51, 49, 59) | 42.40 percentage change in CTX | Standard Deviation 58.62 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 12 months (n=47, 46, 43, 49) | 61.25 percentage change in CTX | Standard Deviation 60.862 |
| 50 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 1 month (n=49, 53, 49, 60) | 13.35 percentage change in CTX | Standard Deviation 29.384 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 12 months (n=47, 46, 43, 49) | 114.11 percentage change in CTX | Standard Deviation 157.485 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 3 months (n=50, 51, 49, 59) | 90.36 percentage change in CTX | Standard Deviation 103.367 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 1 month (n=49, 53, 49, 60) | 21.66 percentage change in CTX | Standard Deviation 46.572 |
| 80 Mcg Transdermal Teriparatide | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | 6 months (n=48, 49, 48, 56) | 127.81 percentage change in CTX | Standard Deviation 152.725 |
p-value: 0.822Wilcoxon Rank Sum Test
p-value: 0.406Wilcoxon Rank Sum Test
p-value: 0.312Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: 0.952Wilcoxon Rank Sum Test
p-value: <0.001Wilcoxon Rank Sum Test
p-value: 0.011Wilcoxon Rank Sum Test
p-value: 0.997Wilcoxon Rank Sum Test
p-value: 0.003Wilcoxon Rank Sum Test
p-value: 0.112Wilcoxon Rank Sum Test
p-value: 0.988Wilcoxon Rank Sum Test
Secondary
Pharmacokinetics Parameters: Area Under the Curve (AUC)
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Time frame: Baseline, 1 Month, 3 Months, and 12 Months
Population: Due to high intra-subject variability, zero participants were analyzed on this outcome measure.
Secondary
Pharmacokinetics Parameters: Maximal Concentration (Cmax)
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Time frame: Baseline, 1 Month, 3 Months, 12 Months
Population: Due to high intra-subject variability, zero participants were analyzed for this outcome measure.
Secondary
Time Course Change of BMD Response at the Lumbar Spine
To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).
Time frame: Baseline to 6 Months and 12 Months
Population: All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| 20 Mcg Subcutaneous Teriparatide | Time Course Change of BMD Response at the Lumbar Spine | 6 months (n=54, 52, 51, 58) | 4.72 percentage change in BMD |
| 20 Mcg Subcutaneous Teriparatide | Time Course Change of BMD Response at the Lumbar Spine | 12 months (n=52, 48, 45, 50) | 8.12 percentage change in BMD |
| 30 Mcg Transdermal Teriparatide | Time Course Change of BMD Response at the Lumbar Spine | 12 months (n=52, 48, 45, 50) | 0.62 percentage change in BMD |
| 30 Mcg Transdermal Teriparatide | Time Course Change of BMD Response at the Lumbar Spine | 6 months (n=54, 52, 51, 58) | 0.19 percentage change in BMD |
| 50 Mcg Transdermal Teriparatide | Time Course Change of BMD Response at the Lumbar Spine | 6 months (n=54, 52, 51, 58) | 0.78 percentage change in BMD |
| 50 Mcg Transdermal Teriparatide | Time Course Change of BMD Response at the Lumbar Spine | 12 months (n=52, 48, 45, 50) | 0.66 percentage change in BMD |
| 80 Mcg Transdermal Teriparatide | Time Course Change of BMD Response at the Lumbar Spine | 6 months (n=54, 52, 51, 58) | 1.19 percentage change in BMD |
| 80 Mcg Transdermal Teriparatide | Time Course Change of BMD Response at the Lumbar Spine | 12 months (n=52, 48, 45, 50) | 1.93 percentage change in BMD |
p-value: <0.00190% CI: [-5.663, -3.392]Mixed Models Analysis
p-value: <0.00190% CI: [-5.086, -2.8]Mixed Models Analysis
p-value: <0.00190% CI: [-4.627, -2.43]Mixed Models Analysis
p-value: <0.00190% CI: [-8.856, -6.151]Mixed Models Analysis
p-value: 0.00190% CI: [-8.835, -6.091]Mixed Models Analysis
p-value: 0.00190% CI: [-7.51, -4.86]Mixed Models Analysis