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Trial · NCT00853723

Comparison Study of PTHrP and PTH to Treat Osteoporosis

NCT00853723, Phase 2, Completed, University of Pittsburgh; results first posted 2016-02-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Comparison Study of PTHrP and PTH to Treat Osteoporosis. Trials, record NCT00853723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853723

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Comparison Study of PTHrP and PTH to Treat Osteoporosis
NCT number
NCT00853723
Status
Completed
Phases
Phase 2
Enrollment
105 participants, actual
Lead sponsor
University of Pittsburgh
Conditions
Osteoporosis
Interventions
Parathyroid hormone related protein (1-36), Parathyroid hormone related protein(1-36), Parathyroid hormone (1-34)
First posted
2009-03-02
Last updated
2016-03-24
Results first posted
2016-02-24
Limitations and caveats
This study was not double-blinded. There was no placebo group in this study. Subjects had higher than anticipated calcium intake and baseline vitamin D levels.

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProcallagen-1 Amino-terminal Peptide (P1NP)Baseline, Day 15, Day 30, Day 60, Day 90
PrimaryCarboxy-terminal Telopeptides of Collagen-1 (CTX)Baseline, Day 15, Day 30, Day 60, Day 90
SecondaryChanges in Bone Mineral Density of the Lumbar Spine.90 days
SecondaryChanges in Bone Mineral Density of the Total Hip.90 days
SecondaryChanges in Bone Mineral Density of the Femoral Neck.90 days
SecondaryChanges in Bone Mineral Density of the Forearm.90 days
SecondaryChanges in Bone Mineral Density of the Distal 1/3 Radius.90 days
SecondaryTotal Serum Calcium (mg/dl)Baseline, Day 15, Day 30, Day 60, Day 90
SecondarySerum PhosphorousBaseline, Day 15, Day 30, Day 60, Day 90
Secondary24 Hour Urine Calcium90 days

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProcallagen-1 Amino-terminal Peptide (P1NP)Baseline, Day 15, Day 30, Day 60, Day 90percentage change from baselineMEAN
SECONDARYChanges in Bone Mineral Density of the Lumbar Spine.90 daysPercent change from baselineMEAN
PRIMARYCarboxy-terminal Telopeptides of Collagen-1 (CTX)Baseline, Day 15, Day 30, Day 60, Day 90percentage change from baselineMEAN
SECONDARYChanges in Bone Mineral Density of the Total Hip.90 daysPercent change from baselineMEAN
SECONDARYChanges in Bone Mineral Density of the Femoral Neck.90 daysPercent change from baselineMEAN
SECONDARYChanges in Bone Mineral Density of the Forearm.90 daysPercent change from baselineMEAN
SECONDARYChanges in Bone Mineral Density of the Distal 1/3 Radius.90 daysPercent change from baselineMEAN
SECONDARYTotal Serum Calcium (mg/dl)Baseline, Day 15, Day 30, Day 60, Day 90mg/dlMEAN
SECONDARYSerum PhosphorousBaseline, Day 15, Day 30, Day 60, Day 90mg/dlMEAN
SECONDARY24 Hour Urine Calcium90 daysmg/gm creatinineMEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group126

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Procallagen-1 Amino-terminal Peptide (P1NP)PTHrP 400 mcg/DayDay 1532.54Standard Error 5.09percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTHrP 600 mcg/DayDay 1523.51Standard Error 7.04percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTH 20 mcg/DayDay 1560.67Standard Error 7.35percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTHrP 400 mcg/DayDay 3048.89Standard Error 5.7percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTHrP 600 mcg/DayDay 3083.14Standard Error 12.48percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTH 20 mcg/DayDay 3097.27Standard Error 10.79percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTHrP 400 mcg/DayDay 6034.71Standard Error 5.78percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTHrP 600 mcg/DayDay 6087.39Standard Error 22.24percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTH 20 mcg/DayDay 60125.46Standard Error 17.46percentage change from baseline
Procallagen-1 Amino-terminal Peptide (P1NP)PTHrP 400 mcg/DayDay 9046.07Standard Error 12.12percentage change from baseline

1 to 10 of 126Source ClinicalTrials.gov

See all 126 results by group

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPTHrP 400 mcg/Day35
Overall StudySTARTEDPTHrP 600 mcg/Day35
Overall StudySTARTEDPTH 20 mcg/Day35
Overall StudyCOMPLETEDPTHrP 400 mcg/Day29
Overall StudyCOMPLETEDPTHrP 600 mcg/Day28
Overall StudyCOMPLETEDPTH 20 mcg/Day33
Overall StudyNOT COMPLETEDPTHrP 400 mcg/Day6
Overall StudyNOT COMPLETEDPTHrP 600 mcg/Day7
Overall StudyNOT COMPLETEDPTH 20 mcg/Day2

Source ClinicalTrials.gov

Adverse events27

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDermatologicSkin and subcutaneous tissue disordersPTHrP 400 mcg/Day1935
otherDermatologicSkin and subcutaneous tissue disordersPTHrP 600 mcg/Day2335
otherDermatologicSkin and subcutaneous tissue disordersPTH 20 mcg/Day1435
otherMusculoskeletalMusculoskeletal and connective tissue disordersPTHrP 400 mcg/Day735
otherMusculoskeletalMusculoskeletal and connective tissue disordersPTHrP 600 mcg/Day835
otherMusculoskeletalMusculoskeletal and connective tissue disordersPTH 20 mcg/Day1035
otherNeurologicNervous system disordersPTHrP 400 mcg/Day1135
otherNeurologicNervous system disordersPTHrP 600 mcg/Day1135
otherNeurologicNervous system disordersPTH 20 mcg/Day1235
otherPsychologicalPsychiatric disordersPTHrP 400 mcg/Day535

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPTHrP 400 mcg/Day
Total, all-cause mortalityPTHrP 600 mcg/Day
Total, all-cause mortalityPTH 20 mcg/Day
Total, other adverse eventsPTHrP 400 mcg/Day3335
Total, other adverse eventsPTHrP 600 mcg/Day3135
Total, other adverse eventsPTH 20 mcg/Day2735
Total, serious adverse eventsPTHrP 400 mcg/Day035
Total, serious adverse eventsPTHrP 600 mcg/Day035
Total, serious adverse eventsPTH 20 mcg/Day035

Source ClinicalTrials.gov

Papers24

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
3043221BACKGROUNDPubMed
6253785BACKGROUNDPubMed
7085851BACKGROUNDPubMed
7273794BACKGROUNDPubMed
7477143BACKGROUNDPubMed
8156938BACKGROUNDPubMed
8592727BACKGROUNDPubMed
8892713BACKGROUNDPubMed
9385122BACKGROUNDPubMed
10639544BACKGROUNDPubMed

1 to 10 of 24

See all 24 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01DK051081Pathophysiology of PTH-related Protein (1-36) in HumansSTEWART, ANDREW F.UNIVERSITY OF PITTSBURGH AT PITTSBURGHNATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES1996 to 2012

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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