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One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study

Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone-related Protein(1-36): Effects on Bone Formation

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00580788
Enrollment
14
Registered
2007-12-27
Start date
2008-01-31
Completion date
2009-12-31
Last updated
2016-02-11

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

Conditions

Humoral Hypercalcemia of Malignancy, Hyperparathyroidism, Osteoporosis

Keywords

Endocrine System Diseases, MusculoSkeletal System Diseases, Hormones, Malignancy, Postmenopausal Women, Bone metabolism

Brief summary

This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrp on markers of bone turnover, and plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.

Detailed description

During this research the investigators administer PTHrP to healthy young volunteers in a controlled, continuous intravenous manner. As research subjects complete the week-long study without adverse effects, the dose of PThrP will be increased in later subjects. In the event of a significant adverse effect, immediate action will be taken to reverse it. The investigators want to estimate the effect of a sustainable level of mild hypercalcemia achieved by a week-long intravenous infusion of PTHrP has on vitamin D metabolism, markers of bone turnover and fractional excretion of calcium.

Interventions

DRUGPTHrP (1-36)

IND # 49,175

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
24 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy caucasian subjects of both sexes between the ages of 24-35 years, who are able to spend one week on the Clinical & Translational Research Center at the University of Pittsburgh Medical Center (UPMC) Montefiore

Exclusion criteria

* Pregnancy * Any cardiac, renal, pulmonary, endocrine, musculoskeletal, hepatic, hematological, malignant or rheumatologic diseases * Body mass index great than 30 * Anemia * Significant alcohol or drug abuse * Baseline hypotension or hypertension * Abnormal screening labs * Use of certain chronic medications excluding oral contraceptives * Receiving an investigational drug in the last 90 days * Previously receiving PTH or PTHrP * African-American race

Design outcomes

Primary

MeasureTime frameDescription
Dose Limiting Toxicity (DLT)12 hours after the infusion was started then q 8 hours for 7 daysDLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall \>30 mm/hg), tachycardia (pulse \> 120), hypertension (systolic BP \>160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous \< 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.
Total Serum Calcium12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion completemg/dl
Ionized Serum Calcium12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion completemg/dl
Serum Phosphorous12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion completemg/dl

Secondary

MeasureTime frameDescription
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Baseline, Daily, and 1 week follow-up% change from baseline
Amino-terminal Peptides of Procollagen 1 (P1NP)Baseline, Daily, and 1 week follow-up% change from baseline
1,25 Vitamin DBaseline and Daily through day 8 then at follow-up visitpg/ml
Parathyroid Hormone (1-84)Baseline and Dailypg/ml
Fractional Excretion of Calciumdaily% calculated from daily second morning void
Bone Specific Alkaline Phosphatase (BSAP)Baseline, Daily, and 1 week follow-up% change from baseline
24 Hour Urine Calcium24 hoursmg/gm creatinine collected on day 7 of PTHrP infusion
Tubular Maximum of Phosphorous (TmP/GFR)dailymg/dl calculated from daily second morning void
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Baseline, Daily, and 1 week follow-up% change from baseline

Countries

United States

Participant flow

Recruitment details

24 subjects were screened and 14 were randomized in the study. Data from 2 subjects was not included in the analysis as there were not enough subjects in that group for analysis. 12 subjects were analyzed.

Participants by arm

ArmCount
Group 1
PTHrP(1-36) 2 picomoles/kg/hr for one week.
3
Group 2
PTHrP(1-36) 4 picomoles/kg/hr for one week.
6
Group 3
PTHrP(1-36) 5 picomoles/kg/hr for one week.
3
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week.
2
Total14

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event0001

Baseline characteristics

CharacteristicGroup 1Group 2Group 3Group 4Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
3 Participants6 Participants3 Participants2 Participants14 Participants
Region of Enrollment
United States
3 participants6 participants3 participants2 participants14 participants
Sex: Female, Male
Female
2 Participants3 Participants2 Participants0 Participants7 Participants
Sex: Female, Male
Male
1 Participants3 Participants1 Participants2 Participants7 Participants

Adverse events

Event typeEG000
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
0 / 30 / 61 / 32 / 2
serious
Total, serious adverse events
0 / 30 / 60 / 30 / 2

Outcome results

Primary

Dose Limiting Toxicity (DLT)

DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall \>30 mm/hg), tachycardia (pulse \> 120), hypertension (systolic BP \>160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous \< 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.

Time frame: 12 hours after the infusion was started then q 8 hours for 7 days

ArmMeasureValue (NUMBER)
Group 1Dose Limiting Toxicity (DLT)0 participants
Group 2Dose Limiting Toxicity (DLT)0 participants
Group 3Dose Limiting Toxicity (DLT)2 participants
Group 4Dose Limiting Toxicity (DLT)2 participants
Primary

Ionized Serum Calcium

mg/dl

Time frame: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Ionized Serum Calcium3P DAY 54.61 mg/dlStandard Error 0.2
Group 1Ionized Serum Calcium11P DAY 24.48 mg/dlStandard Error 0.08
Group 1Ionized Serum Calcium3P DAY 74.84 mg/dlStandard Error 0.16
Group 1Ionized Serum Calcium7A DAY 54.71 mg/dlStandard Error 0.07
Group 1Ionized Serum Calcium7A DAY 34.77 mg/dlStandard Error 0.15
Group 1Ionized Serum CalciumFOLLOW-UP4.68 mg/dlStandard Error 0.08
Group 1Ionized Serum Calcium11P DAY 44.47 mg/dlStandard Error 0.07
Group 1Ionized Serum Calcium3P DAY 34.73 mg/dlStandard Error 0.11
Group 1Ionized Serum Calcium3P DAY 64.72 mg/dlStandard Error 0.13
Group 1Ionized Serum Calcium3P DAY 44.45 mg/dlStandard Error 0.16
Group 1Ionized Serum Calcium11P DAY 34.41 mg/dlStandard Error 0.15
Group 1Ionized Serum Calciumbaseline4.79 mg/dlStandard Error 0.03
Group 1Ionized Serum Calcium11P DAY 74.56 mg/dlStandard Error 0.12
Group 1Ionized Serum Calcium7A DAY 85.00 mg/dlStandard Error 0.11
Group 1Ionized Serum Calcium7A DAY 74.55 mg/dlStandard Error 0.22
Group 1Ionized Serum Calcium7A DAY 64.63 mg/dlStandard Error 0.03
Group 1Ionized Serum Calcium7A DAY 44.75 mg/dlStandard Error 0.14
Group 1Ionized Serum Calcium7A DAY 24.77 mg/dlStandard Error 0.07
Group 1Ionized Serum Calcium11P DAY 14.51 mg/dlStandard Error 0.05
Group 1Ionized Serum Calcium11P DAY 54.60 mg/dlStandard Error 0.13
Group 1Ionized Serum Calcium3P DAY 24.52 mg/dlStandard Error 0.02
Group 1Ionized Serum Calcium11P DAY 64.32 mg/dlStandard Error 0.06
Group 2Ionized Serum Calcium7A DAY 44.90 mg/dlStandard Error 0.13
Group 2Ionized Serum Calciumbaseline4.72 mg/dlStandard Error 0.08
Group 2Ionized Serum Calcium11P DAY 14.77 mg/dlStandard Error 0.08
Group 2Ionized Serum Calcium7A DAY 75.01 mg/dlStandard Error 0.09
Group 2Ionized Serum Calcium3P DAY 75.04 mg/dlStandard Error 0.17
Group 2Ionized Serum Calcium11P DAY 74.87 mg/dlStandard Error 0.19
Group 2Ionized Serum Calcium11P DAY 34.58 mg/dlStandard Error 0.15
Group 2Ionized Serum Calcium7A DAY 24.98 mg/dlStandard Error 0.1
Group 2Ionized Serum Calcium3P DAY 24.99 mg/dlStandard Error 0.06
Group 2Ionized Serum Calcium11P DAY 25.04 mg/dlStandard Error 0.07
Group 2Ionized Serum Calcium7A DAY 35.31 mg/dlStandard Error 0.08
Group 2Ionized Serum Calcium3P DAY 34.99 mg/dlStandard Error 0.1
Group 2Ionized Serum Calcium3P DAY 44.68 mg/dlStandard Error 0.14
Group 2Ionized Serum Calcium11P DAY 44.46 mg/dlStandard Error 0.12
Group 2Ionized Serum Calcium7A DAY 54.82 mg/dlStandard Error 0.09
Group 2Ionized Serum Calcium3P DAY 54.67 mg/dlStandard Error 0.12
Group 2Ionized Serum Calcium11P DAY 54.58 mg/dlStandard Error 0.07
Group 2Ionized Serum Calcium7A DAY 64.77 mg/dlStandard Error 0.1
Group 2Ionized Serum Calcium3P DAY 64.83 mg/dlStandard Error 0.07
Group 2Ionized Serum Calcium11P DAY 64.72 mg/dlStandard Error 0.09
Group 2Ionized Serum Calcium7A DAY 85.43 mg/dlStandard Error 0.18
Group 2Ionized Serum CalciumFOLLOW-UP4.83 mg/dlStandard Error 0.05
Group 3Ionized Serum Calcium3P DAY 25.07 mg/dlStandard Error 0.06
Group 3Ionized Serum Calcium11P DAY 75.24 mg/dlStandard Error 0.02
Group 3Ionized Serum Calcium3P DAY 54.87 mg/dlStandard Error 0.4
Group 3Ionized Serum Calcium7A DAY 25.07 mg/dlStandard Error 0.07
Group 3Ionized Serum Calcium11P DAY 14.75 mg/dlStandard Error 0.04
Group 3Ionized Serum Calcium11P DAY 54.79 mg/dlStandard Error 0.09
Group 3Ionized Serum Calcium11P DAY 34.83 mg/dlStandard Error 0.14
Group 3Ionized Serum CalciumFOLLOW-UP4.80 mg/dlStandard Error 0.06
Group 3Ionized Serum Calcium7A DAY 65.25 mg/dlStandard Error 0.09
Group 3Ionized Serum Calcium3P DAY 75.25 mg/dlStandard Error 0.31
Group 3Ionized Serum Calcium7A DAY 85.69 mg/dlStandard Error 0.1
Group 3Ionized Serum Calcium3P DAY 65.35 mg/dlStandard Error 0.03
Group 3Ionized Serum Calcium7A DAY 45.11 mg/dlStandard Error 0.09
Group 3Ionized Serum Calcium3P DAY 34.91 mg/dlStandard Error 0.16
Group 3Ionized Serum Calcium7A DAY 75.55 mg/dlStandard Error 0.27
Group 3Ionized Serum Calcium3P DAY 44.72 mg/dlStandard Error 0.17
Group 3Ionized Serum Calcium7A DAY 35.25 mg/dlStandard Error 0.13
Group 3Ionized Serum Calciumbaseline4.55 mg/dlStandard Error 0.15
Group 3Ionized Serum Calcium11P DAY 44.69 mg/dlStandard Error 0.06
Group 3Ionized Serum Calcium11P DAY 24.84 mg/dlStandard Error 0
Group 3Ionized Serum Calcium11P DAY 65.19 mg/dlStandard Error 0.21
Group 3Ionized Serum Calcium7A DAY 54.97 mg/dlStandard Error 0.12
p-value: <0.0001Mixed Models Analysis
Primary

Serum Phosphorous

mg/dl

Time frame: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Serum Phosphorous11P DAY 24.13 mg/dlStandard Error 0.29
Group 1Serum Phosphorous11P DAY 53.93 mg/dlStandard Error 0.23
Group 1Serum Phosphorous11P DAY 34.03 mg/dlStandard Error 0.26
Group 1Serum Phosphorous11P DAY 13.87 mg/dlStandard Error 0.26
Group 1Serum Phosphorous3P DAY 53.57 mg/dlStandard Error 0.29
Group 1Serum Phosphorous7A DAY 44.07 mg/dlStandard Error 0.22
Group 1Serum Phosphorous3P DAY 74.07 mg/dlStandard Error 0.09
Group 1Serum Phosphorous7A DAY 53.87 mg/dlStandard Error 0.19
Group 1Serum Phosphorous3P DAY 43.90 mg/dlStandard Error 0.1
Group 1Serum Phosphorous7A DAY 33.90 mg/dlStandard Error 0.26
Group 1Serum Phosphorous11P DAY 43.67 mg/dlStandard Error 0.28
Group 1Serum PhosphorousFOLLOW-UP3.57 mg/dlStandard Error 0.38
Group 1Serum Phosphorous11P DAY 63.93 mg/dlStandard Error 0.18
Group 1Serum Phosphorous7A DAY 74.30 mg/dlStandard Error 0.1
Group 1Serum Phosphorous7A DAY 84.43 mg/dlStandard Error 0.15
Group 1Serum Phosphorous3P DAY 63.67 mg/dlStandard Error 0.03
Group 1Serum Phosphorousbaseline3.55 mg/dlStandard Error 0.15
Group 1Serum Phosphorous7A DAY 24.07 mg/dlStandard Error 0.15
Group 1Serum Phosphorous7A DAY 64.00 mg/dlStandard Error 0.06
Group 1Serum Phosphorous3P DAY 23.63 mg/dlStandard Error 0.33
Group 1Serum Phosphorous11P DAY 74.20 mg/dlStandard Error 0.26
Group 1Serum Phosphorous3P DAY 33.53 mg/dlStandard Error 0.24
Group 2Serum Phosphorous3P DAY 63.80 mg/dlStandard Error 0.14
Group 2Serum Phosphorous11P DAY 13.90 mg/dlStandard Error 0.16
Group 2Serum Phosphorous11P DAY 23.52 mg/dlStandard Error 0.19
Group 2Serum Phosphorous7A DAY 33.77 mg/dlStandard Error 0.19
Group 2Serum Phosphorous7A DAY 74.28 mg/dlStandard Error 0.12
Group 2Serum Phosphorous7A DAY 24.20 mg/dlStandard Error 0.15
Group 2Serum Phosphorous3P DAY 23.50 mg/dlStandard Error 0.23
Group 2Serum Phosphorous3P DAY 33.53 mg/dlStandard Error 0.18
Group 2Serum Phosphorous11P DAY 33.58 mg/dlStandard Error 0.17
Group 2Serum Phosphorous7A DAY 43.90 mg/dlStandard Error 0.13
Group 2Serum Phosphorous3P DAY 43.37 mg/dlStandard Error 0.2
Group 2Serum Phosphorous11P DAY 43.48 mg/dlStandard Error 0.14
Group 2Serum Phosphorous7A DAY 54.02 mg/dlStandard Error 0.14
Group 2Serum Phosphorous3P DAY 53.35 mg/dlStandard Error 0.2
Group 2Serum Phosphorous11P DAY 53.45 mg/dlStandard Error 0.2
Group 2Serum Phosphorous7A DAY 64.00 mg/dlStandard Error 0.1
Group 2Serum Phosphorousbaseline3.63 mg/dlStandard Error 0.14
Group 2Serum Phosphorous11P DAY 63.90 mg/dlStandard Error 0.1
Group 2Serum Phosphorous3P DAY 73.62 mg/dlStandard Error 0.2
Group 2Serum Phosphorous11P DAY 73.62 mg/dlStandard Error 0.19
Group 2Serum Phosphorous7A DAY 84.10 mg/dlStandard Error 0.1
Group 2Serum PhosphorousFOLLOW-UP3.48 mg/dlStandard Error 0.26
Group 3Serum Phosphorous11P DAY 53.87 mg/dlStandard Error 0.32
Group 3Serum Phosphorous7A DAY 23.63 mg/dlStandard Error 0.44
Group 3Serum Phosphorous11P DAY 73.60 mg/dlStandard Error 0.3
Group 3Serum Phosphorous7A DAY 63.63 mg/dlStandard Error 0.35
Group 3Serum Phosphorous7A DAY 73.73 mg/dlStandard Error 0.38
Group 3Serum Phosphorous11P DAY 14.03 mg/dlStandard Error 0.12
Group 3Serum Phosphorous3P DAY 63.73 mg/dlStandard Error 0.19
Group 3Serum Phosphorous7A DAY 33.43 mg/dlStandard Error 0.39
Group 3Serum PhosphorousFOLLOW-UP3.87 mg/dlStandard Error 0.09
Group 3Serum Phosphorous11P DAY 63.93 mg/dlStandard Error 0.09
Group 3Serum Phosphorous11P DAY 23.63 mg/dlStandard Error 0.19
Group 3Serum Phosphorous3P DAY 43.33 mg/dlStandard Error 0.32
Group 3Serum Phosphorous7A DAY 83.40 mg/dlStandard Error 0.23
Group 3Serum Phosphorous11P DAY 43.63 mg/dlStandard Error 0.27
Group 3Serum Phosphorous7A DAY 43.30 mg/dlStandard Error 0.4
Group 3Serum Phosphorous3P DAY 73.50 mg/dlStandard Error 0.2
Group 3Serum Phosphorous7A DAY 53.20 mg/dlStandard Error 0.3
Group 3Serum Phosphorous11P DAY 33.70 mg/dlStandard Error 0.15
Group 3Serum Phosphorous3P DAY 23.70 mg/dlStandard Error 0.2
Group 3Serum Phosphorous3P DAY 53.10 mg/dlStandard Error 0.21
Group 3Serum Phosphorous3P DAY 33.60 mg/dlStandard Error 0.23
Group 3Serum Phosphorousbaseline3.55 mg/dlStandard Error 0.45
p-value: >0.05Mixed Models Analysis
Primary

Total Serum Calcium

mg/dl

Time frame: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Total Serum Calcium3P DAY 59.50 mg/dlStandard Error 0.15
Group 1Total Serum Calcium11P DAY 29.67 mg/dlStandard Error 0.09
Group 1Total Serum Calcium3P DAY 29.57 mg/dlStandard Error 0.09
Group 1Total Serum Calcium7A DAY 59.30 mg/dlStandard Error 0.12
Group 1Total Serum Calcium7A DAY 39.6 mg/dlStandard Error 0.1
Group 1Total Serum Calcium3P DAY 79.70 mg/dlStandard Error 0.15
Group 1Total Serum Calcium11P DAY 49.37 mg/dlStandard Error 0.09
Group 1Total Serum Calcium3P DAY 39.73 mg/dlStandard Error 0.09
Group 1Total Serum Calciumbaseline9.37 mg/dlStandard Error 0.07
Group 1Total Serum Calcium3P DAY 49.40 mg/dlStandard Error 0.17
Group 1Total Serum Calcium11P DAY 39.40 mg/dlStandard Error 0.17
Group 1Total Serum Calcium11P DAY 79.60 mg/dlStandard Error 0.15
Group 1Total Serum Calcium7A DAY 49.47 mg/dlStandard Error 0.03
Group 1Total Serum Calcium7A DAY 79.40 mg/dlStandard Error 0.1
Group 1Total Serum Calcium3P DAY 69.43 mg/dlStandard Error 0.15
Group 1Total Serum Calcium7A DAY 89.83 mg/dlStandard Error 0.13
Group 1Total Serum Calcium7A DAY 29.4 mg/dlStandard Error 0.17
Group 1Total Serum Calcium7A DAY 69.57 mg/dlStandard Error 0.07
Group 1Total Serum CalciumFOLLOW-UP9.33 mg/dlStandard Error 0.07
Group 1Total Serum Calcium11P DAY 19.67 mg/dlStandard Error 0.09
Group 1Total Serum Calcium11P DAY 59.43 mg/dlStandard Error 0.09
Group 1Total Serum Calcium11P DAY 69.43 mg/dlStandard Error 0.13
Group 2Total Serum Calcium3P DAY 610.08 mg/dlStandard Error 0.12
Group 2Total Serum Calciumbaseline9.58 mg/dlStandard Error 0.12
Group 2Total Serum Calcium11P DAY 19.80 mg/dlStandard Error 0.16
Group 2Total Serum Calcium7A DAY 210.05 mg/dlStandard Error 0.19
Group 2Total Serum Calcium3P DAY 710.22 mg/dlStandard Error 0.32
Group 2Total Serum Calcium11P DAY 710.27 mg/dlStandard Error 0.28
Group 2Total Serum Calcium7A DAY 810.67 mg/dlStandard Error 0.4
Group 2Total Serum CalciumFOLLOW-UP9.80 mg/dlStandard Error 0.12
Group 2Total Serum Calcium3P DAY 210.28 mg/dlStandard Error 0.14
Group 2Total Serum Calcium11P DAY 210.32 mg/dlStandard Error 0.14
Group 2Total Serum Calcium7A DAY 310.40 mg/dlStandard Error 0.18
Group 2Total Serum Calcium3P DAY 310.42 mg/dlStandard Error 0.14
Group 2Total Serum Calcium11P DAY 39.73 mg/dlStandard Error 0.1
Group 2Total Serum Calcium7A DAY 410.00 mg/dlStandard Error 0.24
Group 2Total Serum Calcium3P DAY 49.92 mg/dlStandard Error 0.21
Group 2Total Serum Calcium11P DAY 49.48 mg/dlStandard Error 0.11
Group 2Total Serum Calcium7A DAY 59.62 mg/dlStandard Error 0.12
Group 2Total Serum Calcium3P DAY 59.83 mg/dlStandard Error 0.2
Group 2Total Serum Calcium11P DAY 59.45 mg/dlStandard Error 0.13
Group 2Total Serum Calcium7A DAY 69.83 mg/dlStandard Error 0.2
Group 2Total Serum Calcium11P DAY 69.67 mg/dlStandard Error 0.21
Group 2Total Serum Calcium7A DAY 710.13 mg/dlStandard Error 0.28
Group 3Total Serum Calcium11P DAY 210.23 mg/dlStandard Error 0.26
Group 3Total Serum Calcium7A DAY 710.90 mg/dlStandard Error 0.46
Group 3Total Serum Calcium7A DAY 510.53 mg/dlStandard Error 0.15
Group 3Total Serum Calcium3P DAY 210.47 mg/dlStandard Error 0.3
Group 3Total Serum Calcium11P DAY 610.43 mg/dlStandard Error 0.47
Group 3Total Serum Calcium3P DAY 510.27 mg/dlStandard Error 0.44
Group 3Total Serum CalciumFOLLOW-UP9.17 mg/dlStandard Error 0.24
Group 3Total Serum Calcium11P DAY 19.67 mg/dlStandard Error 0.2
Group 3Total Serum Calcium11P DAY 59.80 mg/dlStandard Error 0.2
Group 3Total Serum Calcium7A DAY 811.17 mg/dlStandard Error 0.35
Group 3Total Serum Calciumbaseline9.2 mg/dlStandard Error 0.25
Group 3Total Serum Calcium7A DAY 610.53 mg/dlStandard Error 0.22
Group 3Total Serum Calcium11P DAY 710.73 mg/dlStandard Error 0.5
Group 3Total Serum Calcium11P DAY 39.93 mg/dlStandard Error 0.38
Group 3Total Serum Calcium3P DAY 710.70 mg/dlStandard Error 0.46
Group 3Total Serum Calcium7A DAY 410.3 mg/dlStandard Error 0.23
Group 3Total Serum Calcium3P DAY 310.67 mg/dlStandard Error 0.27
Group 3Total Serum Calcium3P DAY 610.83 mg/dlStandard Error 0.27
Group 3Total Serum Calcium3P DAY 410.33 mg/dlStandard Error 0.34
Group 3Total Serum Calcium7A DAY 310.73 mg/dlStandard Error 0.57
Group 3Total Serum Calcium7A DAY 210.17 mg/dlStandard Error 0.2
Group 3Total Serum Calcium11P DAY 410.00 mg/dlStandard Error 0.15
p-value: <0.0001Mixed Models Analysis
Secondary

1,25 Vitamin D

pg/ml

Time frame: Baseline and Daily through day 8 then at follow-up visit

ArmMeasureGroupValue (MEAN)Dispersion
Group 11,25 Vitamin DDay 432.23 pg/mlStandard Error 2.32
Group 11,25 Vitamin Dbaseline34.13 pg/mlStandard Error 3.03
Group 11,25 Vitamin DDay 642.77 pg/mlStandard Error 4.23
Group 11,25 Vitamin DDay 532.27 pg/mlStandard Error 1.8
Group 11,25 Vitamin Dfollow-up40.10 pg/mlStandard Error 4.01
Group 11,25 Vitamin DDay 832.37 pg/mlStandard Error 3.17
Group 11,25 Vitamin DDay 330.13 pg/mlStandard Error 4.57
Group 11,25 Vitamin DDay 238.40 pg/mlStandard Error 5.12
Group 11,25 Vitamin DDay 740.53 pg/mlStandard Error 4.38
Group 21,25 Vitamin DDay 833.43 pg/mlStandard Error 3.13
Group 21,25 Vitamin Dbaseline45.08 pg/mlStandard Error 4.24
Group 21,25 Vitamin DDay 245.88 pg/mlStandard Error 1.53
Group 21,25 Vitamin DDay 336.58 pg/mlStandard Error 4.17
Group 21,25 Vitamin DDay 440.38 pg/mlStandard Error 4.18
Group 21,25 Vitamin Dfollow-up45.78 pg/mlStandard Error 4.72
Group 21,25 Vitamin DDay 546.40 pg/mlStandard Error 6.12
Group 21,25 Vitamin DDay 634.90 pg/mlStandard Error 4.91
Group 21,25 Vitamin DDay 737.12 pg/mlStandard Error 3.58
Group 31,25 Vitamin DDay 532.07 pg/mlStandard Error 3.79
Group 31,25 Vitamin DDay 435.17 pg/mlStandard Error 2.63
Group 31,25 Vitamin DDay 239.77 pg/mlStandard Error 2.69
Group 31,25 Vitamin DDay 635.37 pg/mlStandard Error 2.98
Group 31,25 Vitamin DDay 336.73 pg/mlStandard Error 2.75
Group 31,25 Vitamin DDay 830.63 pg/mlStandard Error 4.79
Group 31,25 Vitamin Dbaseline39.0 pg/mlStandard Error 4.09
Group 31,25 Vitamin Dfollow-up36.33 pg/mlStandard Error 2.11
Group 31,25 Vitamin DDay 731.17 pg/mlStandard Error 6.84
p-value: >0.05Mixed Models Analysis
p-value: 0.01Mixed Models Analysis
Secondary

24 Hour Urine Calcium

mg/gm creatinine collected on day 7 of PTHrP infusion

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Group 124 Hour Urine Calcium121.64 mg/gm creatinineStandard Error 9.87
Group 224 Hour Urine Calcium283.43 mg/gm creatinineStandard Error 30.93
Group 324 Hour Urine Calcium320.23 mg/gm creatinineStandard Error 41.32
Secondary

Amino-terminal Peptides of Procollagen 1 (P1NP)

% change from baseline

Time frame: Baseline, Daily, and 1 week follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)Day 6-8.42 % changeStandard Error 5.07
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)Day 8-16.03 % changeStandard Error 5.03
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)Day 7-12.59 % changeStandard Error 6.17
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)Day 2-1.05 % changeStandard Error 4.95
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)follow-up-7.12 % changeStandard Error 2.29
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)Day 3-6.83 % changeStandard Error 2.78
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)baseline0.00 % changeStandard Error 0
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)Day 4-12.16 % changeStandard Error 0.57
Group 1Amino-terminal Peptides of Procollagen 1 (P1NP)Day 5-5.63 % changeStandard Error 2.27
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)Day 2-17.49 % changeStandard Error 5.93
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)Day 6-31.71 % changeStandard Error 7.5
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)Day 8-36.60 % changeStandard Error 9.64
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)baseline0.00 % changeStandard Error 0
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)Day 7-30.98 % changeStandard Error 8.87
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)Day 3-30.44 % changeStandard Error 7.1
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)Day 4-25.66 % changeStandard Error 9.55
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)follow-up0.60 % changeStandard Error 9.58
Group 2Amino-terminal Peptides of Procollagen 1 (P1NP)Day 5-21.27 % changeStandard Error 8.01
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)follow-up46.67 % changeStandard Error 17.34
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)Day 5-45.04 % changeStandard Error 3.07
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)Day 7-39.88 % changeStandard Error 2.78
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)baseline0.00 % changeStandard Error 0
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)Day 2-23.88 % changeStandard Error 6.05
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)Day 3-37.77 % changeStandard Error 6.56
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)Day 4-39.44 % changeStandard Error 4.46
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)Day 6-39.55 % changeStandard Error 1.75
Group 3Amino-terminal Peptides of Procollagen 1 (P1NP)Day 8-38.53 % changeStandard Error 3.4
p-value: <0.0001Mixed Models Analysis
p-value: 0.01Mixed Models Analysis
Secondary

Bone Specific Alkaline Phosphatase (BSAP)

% change from baseline

Time frame: Baseline, Daily, and 1 week follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Bone Specific Alkaline Phosphatase (BSAP)Day 4-5.82 % changeStandard Error 1.58
Group 1Bone Specific Alkaline Phosphatase (BSAP)follow-up-1.25 % changeStandard Error 2.7
Group 1Bone Specific Alkaline Phosphatase (BSAP)Day 6-8.16 % changeStandard Error 9.32
Group 1Bone Specific Alkaline Phosphatase (BSAP)Day 5-0.33 % changeStandard Error 0.33
Group 1Bone Specific Alkaline Phosphatase (BSAP)baseline0.00 % changeStandard Error 0
Group 1Bone Specific Alkaline Phosphatase (BSAP)Day 8-7.80 % changeStandard Error 8.66
Group 1Bone Specific Alkaline Phosphatase (BSAP)Day 3-6.35 % changeStandard Error 4.84
Group 1Bone Specific Alkaline Phosphatase (BSAP)Day 2-12.53 % changeStandard Error 8.6
Group 1Bone Specific Alkaline Phosphatase (BSAP)Day 7-11.91 % changeStandard Error 10.38
Group 2Bone Specific Alkaline Phosphatase (BSAP)Day 5-9.64 % changeStandard Error 4.73
Group 2Bone Specific Alkaline Phosphatase (BSAP)baseline0.00 % changeStandard Error 0
Group 2Bone Specific Alkaline Phosphatase (BSAP)Day 2-1.17 % changeStandard Error 4.1
Group 2Bone Specific Alkaline Phosphatase (BSAP)Day 3-1.44 % changeStandard Error 3.07
Group 2Bone Specific Alkaline Phosphatase (BSAP)Day 4-3.79 % changeStandard Error 4.65
Group 2Bone Specific Alkaline Phosphatase (BSAP)Day 6-10.88 % changeStandard Error 4.04
Group 2Bone Specific Alkaline Phosphatase (BSAP)Day 7-16.78 % changeStandard Error 2.58
Group 2Bone Specific Alkaline Phosphatase (BSAP)Day 8-14.01 % changeStandard Error 3.72
Group 2Bone Specific Alkaline Phosphatase (BSAP)follow-up6.16 % changeStandard Error 3.81
Group 3Bone Specific Alkaline Phosphatase (BSAP)Day 334.77 % changeStandard Error 6.53
Group 3Bone Specific Alkaline Phosphatase (BSAP)baseline0.00 % changeStandard Error 0
Group 3Bone Specific Alkaline Phosphatase (BSAP)Day 79.86 % changeStandard Error 4.01
Group 3Bone Specific Alkaline Phosphatase (BSAP)Day 224.54 % changeStandard Error 7.01
Group 3Bone Specific Alkaline Phosphatase (BSAP)follow-up18.23 % changeStandard Error 2.22
Group 3Bone Specific Alkaline Phosphatase (BSAP)Day 513.61 % changeStandard Error 9.76
Group 3Bone Specific Alkaline Phosphatase (BSAP)Day 419.49 % changeStandard Error 8.23
Group 3Bone Specific Alkaline Phosphatase (BSAP)Day 815.27 % changeStandard Error 11.63
Group 3Bone Specific Alkaline Phosphatase (BSAP)Day 69.02 % changeStandard Error 8.94
p-value: 0.001Mixed Models Analysis
p-value: 0.01Mixed Models Analysis
Secondary

Fractional Excretion of Calcium

% calculated from daily second morning void

Time frame: daily

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Fractional Excretion of CalciumDay 21.31 % of filtered loadStandard Error 0.59
Group 1Fractional Excretion of CalciumDay 53.05 % of filtered loadStandard Error 0.7
Group 1Fractional Excretion of CalciumDay 41.57 % of filtered loadStandard Error 0.25
Group 1Fractional Excretion of CalciumBaseline1.93 % of filtered loadStandard Error 0.91
Group 1Fractional Excretion of CalciumDay 72.72 % of filtered loadStandard Error 0.28
Group 1Fractional Excretion of CalciumDay 63.37 % of filtered loadStandard Error 0.67
Group 1Fractional Excretion of CalciumDay 31.07 % of filtered loadStandard Error 0.51
Group 2Fractional Excretion of CalciumDay 42.79 % of filtered loadStandard Error 0.76
Group 2Fractional Excretion of CalciumBaseline2.57 % of filtered loadStandard Error 0.73
Group 2Fractional Excretion of CalciumDay 22.26 % of filtered loadStandard Error 0.46
Group 2Fractional Excretion of CalciumDay 32.85 % of filtered loadStandard Error 0.61
Group 2Fractional Excretion of CalciumDay 52.05 % of filtered loadStandard Error 0.46
Group 2Fractional Excretion of CalciumDay 62.75 % of filtered loadStandard Error 0.25
Group 2Fractional Excretion of CalciumDay 73.94 % of filtered loadStandard Error 0.38
Group 3Fractional Excretion of CalciumDay 53.12 % of filtered loadStandard Error 0.46
Group 3Fractional Excretion of CalciumDay 24.11 % of filtered loadStandard Error 2.42
Group 3Fractional Excretion of CalciumDay 74.13 % of filtered loadStandard Error 0.73
Group 3Fractional Excretion of CalciumDay 65.42 % of filtered loadStandard Error 2.23
Group 3Fractional Excretion of CalciumDay 42.14 % of filtered loadStandard Error 0.4
Group 3Fractional Excretion of CalciumDay 33.27 % of filtered loadStandard Error 0.45
Group 3Fractional Excretion of CalciumBaseline2.38 % of filtered loadStandard Error 0.59
p-value: 0.002Mixed Models Analysis
Secondary

Parathyroid Hormone (1-84)

pg/ml

Time frame: Baseline and Daily

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Parathyroid Hormone (1-84)Day 719.40 pg/mlStandard Error 4.03
Group 1Parathyroid Hormone (1-84)Day 522.37 pg/mlStandard Error 5.1
Group 1Parathyroid Hormone (1-84)Day 812.60 pg/mlStandard Error 3.58
Group 1Parathyroid Hormone (1-84)baseline42.97 pg/mlStandard Error 2.86
Group 1Parathyroid Hormone (1-84)follow-up56.37 pg/mlStandard Error 5.18
Group 1Parathyroid Hormone (1-84)Day 426.77 pg/mlStandard Error 3.24
Group 1Parathyroid Hormone (1-84)Day 223.47 pg/mlStandard Error 1.48
Group 1Parathyroid Hormone (1-84)Day 321.43 pg/mlStandard Error 3.65
Group 1Parathyroid Hormone (1-84)Day 621.13 pg/mlStandard Error 5.88
Group 2Parathyroid Hormone (1-84)baseline30.70 pg/mlStandard Error 5.56
Group 2Parathyroid Hormone (1-84)Day 75.67 pg/mlStandard Error 1.2
Group 2Parathyroid Hormone (1-84)Day 35.23 pg/mlStandard Error 1.75
Group 2Parathyroid Hormone (1-84)Day 57.54 pg/mlStandard Error 1.8
Group 2Parathyroid Hormone (1-84)Day 83.00 pg/mlStandard Error 0
Group 2Parathyroid Hormone (1-84)Day 27.82 pg/mlStandard Error 1.5
Group 2Parathyroid Hormone (1-84)Day 47.88 pg/mlStandard Error 3.21
Group 2Parathyroid Hormone (1-84)follow-up31.60 pg/mlStandard Error 2.63
Group 2Parathyroid Hormone (1-84)Day 66.57 pg/mlStandard Error 2.24
Group 3Parathyroid Hormone (1-84)follow-up44.20 pg/mlStandard Error 10.87
Group 3Parathyroid Hormone (1-84)Day 63.00 pg/mlStandard Error 0
Group 3Parathyroid Hormone (1-84)Day 33.00 pg/mlStandard Error 0
Group 3Parathyroid Hormone (1-84)Day 43.00 pg/mlStandard Error 0
Group 3Parathyroid Hormone (1-84)baseline48.27 pg/mlStandard Error 15.93
Group 3Parathyroid Hormone (1-84)Day 23.60 pg/mlStandard Error 0.5
Group 3Parathyroid Hormone (1-84)Day 53.00 pg/mlStandard Error 0
Group 3Parathyroid Hormone (1-84)Day 73.00 pg/mlStandard Error 0
Group 3Parathyroid Hormone (1-84)Day 83.00 pg/mlStandard Error 0
p-value: <0.05Mixed Models Analysis
Secondary

Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)

% change from baseline

Time frame: Baseline, Daily, and 1 week follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 232.86 % changeStandard Error 23.41
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 541.29 % changeStandard Error 20.06
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 735.04 % changeStandard Error 21.44
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 428.32 % changeStandard Error 20.26
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 865.77 % changeStandard Error 30.43
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 326.73 % changeStandard Error 23.19
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 611.41 % changeStandard Error 12.63
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)follow-up-14.95 % changeStandard Error 2.97
Group 1Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)baseline0.00 % changeStandard Error 0
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)baseline0.00 % changeStandard Error 0
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 6123.08 % changeStandard Error 28.62
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 582.36 % changeStandard Error 20.62
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 391.53 % changeStandard Error 28.94
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 7161.55 % changeStandard Error 41.54
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)follow-up-3.33 % changeStandard Error 6.68
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 490.86 % changeStandard Error 32.25
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 8214.90 % changeStandard Error 59.26
Group 2Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 287.75 % changeStandard Error 18.79
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 8108.69 % changeStandard Error 34.29
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 388.51 % changeStandard Error 19.99
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 489.57 % changeStandard Error 20.22
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 5116.58 % changeStandard Error 13.85
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)follow-up-9.02 % changeStandard Error 7.19
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)baseline0.00 % changeStandard Error 0
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 254.21 % changeStandard Error 10.64
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 6150.82 % changeStandard Error 48.26
Group 3Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)Day 7176.42 % changeStandard Error 50.08
p-value: <0.008Mixed Models Analysis
p-value: >0.05Mixed Models Analysis
Secondary

Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)

% change from baseline

Time frame: Baseline, Daily, and 1 week follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 471.19 % changeStandard Error 18.88
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)follow-up-35.73 % changeStandard Error 11.53
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 674.09 % changeStandard Error 26.72
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 579.39 % changeStandard Error 23.89
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)baseline0.00 % changeStandard Error 0
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 8110.61 % changeStandard Error 30.92
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 366.67 % changeStandard Error 32.24
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 259.78 % changeStandard Error 18.14
Group 1Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 7109.27 % changeStandard Error 29.39
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 5167.27 % changeStandard Error 25.3
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)baseline0.00 % changeStandard Error 0
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 2147.12 % changeStandard Error 40.72
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 3180.27 % changeStandard Error 44.45
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 4167.01 % changeStandard Error 47.01
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 6239.51 % changeStandard Error 49.42
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 7283.15 % changeStandard Error 65.65
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 8368.31 % changeStandard Error 93.63
Group 2Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)follow-up-8.60 % changeStandard Error 11.15
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 3148.45 % changeStandard Error 36.8
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)baseline0.00 % changeStandard Error 0
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 7267.89 % changeStandard Error 104.52
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 2105.06 % changeStandard Error 11.54
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)follow-up-41.33 % changeStandard Error 20.38
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 5174.58 % changeStandard Error 47.26
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 4165.16 % changeStandard Error 40.29
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 8140.58 % changeStandard Error 78.58
Group 3Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)Day 6230.42 % changeStandard Error 54.1
p-value: <0.0001Mixed Models Analysis
p-value: >0.05Mixed Models Analysis
Secondary

Tubular Maximum of Phosphorous (TmP/GFR)

mg/dl calculated from daily second morning void

Time frame: daily

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Tubular Maximum of Phosphorous (TmP/GFR)Day 24.48 mg/dlStandard Error 0.2
Group 1Tubular Maximum of Phosphorous (TmP/GFR)Day 34.28 mg/dlStandard Error 0.3
Group 1Tubular Maximum of Phosphorous (TmP/GFR)Day 54.43 mg/dlStandard Error 0.02
Group 1Tubular Maximum of Phosphorous (TmP/GFR)Day 44.42 mg/dlStandard Error 0.31
Group 1Tubular Maximum of Phosphorous (TmP/GFR)Baseline3.43 mg/dlStandard Error 0.26
Group 1Tubular Maximum of Phosphorous (TmP/GFR)Day 74.15 mg/dlStandard Error 0.08
Group 1Tubular Maximum of Phosphorous (TmP/GFR)Day 64.90 mg/dlStandard Error 0.08
Group 2Tubular Maximum of Phosphorous (TmP/GFR)Day 24.08 mg/dlStandard Error 0.23
Group 2Tubular Maximum of Phosphorous (TmP/GFR)Baseline3.91 mg/dlStandard Error 0.23
Group 2Tubular Maximum of Phosphorous (TmP/GFR)Day 33.74 mg/dlStandard Error 0.26
Group 2Tubular Maximum of Phosphorous (TmP/GFR)Day 53.95 mg/dlStandard Error 0.34
Group 2Tubular Maximum of Phosphorous (TmP/GFR)Day 63.98 mg/dlStandard Error 0.11
Group 2Tubular Maximum of Phosphorous (TmP/GFR)Day 73.98 mg/dlStandard Error 0.19
Group 2Tubular Maximum of Phosphorous (TmP/GFR)Day 43.75 mg/dlStandard Error 0.31
Group 3Tubular Maximum of Phosphorous (TmP/GFR)Baseline3.38 mg/dlStandard Error 0.35
Group 3Tubular Maximum of Phosphorous (TmP/GFR)Day 72.95 mg/dlStandard Error 0.28
Group 3Tubular Maximum of Phosphorous (TmP/GFR)Day 23.47 mg/dlStandard Error 0.46
Group 3Tubular Maximum of Phosphorous (TmP/GFR)Day 63.38 mg/dlStandard Error 0.35
Group 3Tubular Maximum of Phosphorous (TmP/GFR)Day 33.25 mg/dlStandard Error 0.5
Group 3Tubular Maximum of Phosphorous (TmP/GFR)Day 43.15 mg/dlStandard Error 0.45
Group 3Tubular Maximum of Phosphorous (TmP/GFR)Day 53.37 mg/dlStandard Error 0.45
p-value: 0.61Mixed Models Analysis

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