Trial · NCT00473265
Bone Properties in Hypoparathyroidism: Effects of PTH
NCT00473265, Phase 2, Phase 3, Completed, John P. Bilezikian; results first posted 2015-07-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bone Properties in Hypoparathyroidism: Effects of PTH. Trials, record NCT00473265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00473265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bone Properties in Hypoparathyroidism: Effects of PTH
- NCT number
- NCT00473265
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 68 participants, actual
- Lead sponsor
- John P. Bilezikian
- Conditions
- Hypoparathyroidism
- Interventions
- PTH
- First posted
- 2007-05-15
- Last updated
- 2015-07-16
- Results first posted
- 2015-07-16
- Limitations and caveats
- Only 16 subjects received a bone biopsy, which is why many of the measurements were only analyzed in 16 subjects. In total, data was only analyzed for the first 30 subjects analyzed for data.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Requirements for Calcium Supplementation | 2 years | Serum and urinary calcium levels maintained by change in requirements for calcium supplementation |
| Secondary | Percent Change in BMD From Baseline to 24 Months by DXA | baseline versus 24 months | Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA). |
| Secondary | Trabecular Width | baseline versus two years | Trabecular width was obtained from histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular width is the thickness of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. |
| Secondary | Trabecular Number | baseline versus two years | trabecular number done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular number is the number of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. |
| Secondary | Cortical Porosity | baseline versus two years | Cortical porosity done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Cortical Porosity measures how many tiny holes there are in the solid bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. |
| Secondary | Mineralizing Surface | baseline versus one year | Mineralizing surface done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Mineralizing surface measures how much of bone is getting new mineral put on it. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Requirements for Calcium Supplementation | 2 years | Only the first 30 participants to complete 24 months in the study were analyzed | grams per day of calcium supplementation | MEAN |
| SECONDARY | Percent Change in BMD From Baseline to 24 Months by DXA | baseline versus 24 months | Only the first 30 participants who completed 24 months of the study were analyzed | percentage of change to BMD | MEAN |
| SECONDARY | Trabecular Width | baseline versus two years | Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment. | micrometers | MEAN |
| SECONDARY | Trabecular Number | baseline versus two years | Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment. | mm^-1 | MEAN |
| SECONDARY | Cortical Porosity | baseline versus two years | Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment. | percentage of porosity | MEAN |
| SECONDARY | Mineralizing Surface | baseline versus one year | Only 14 subjects had paird bone biopsies obtained at baseline and after 12 months of PTH(1-84) treatment. | percentage of surface | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Requirements for Calcium Supplementation | PTH1-84 | Starting requirements | 3.03 | Standard Deviation 2.32 | grams per day of calcium supplementation |
| Requirements for Calcium Supplementation | PTH1-84 | Requirements at month 24 | 1.66 | Standard Deviation 1.26 | grams per day of calcium supplementation |
| Percent Change in BMD From Baseline to 24 Months by DXA | PTH1-84 | Lumbar Spine BMD | 2.9 | Standard Deviation 4 | percentage of change to BMD |
| Percent Change in BMD From Baseline to 24 Months by DXA | PTH1-84 | Femoral Neck BMD | 0.95 | Standard Deviation .2 | percentage of change to BMD |
| Percent Change in BMD From Baseline to 24 Months by DXA | PTH1-84 | Distal 1/3 Radius BMD | -2.4 | Standard Deviation 4 | percentage of change to BMD |
| Trabecular Width | PTH1-84 | Baseline | 144 | Standard Deviation 34 | micrometers |
| Trabecular Width | PTH1-84 | Year 2 | 128 | Standard Deviation 34 | micrometers |
| Trabecular Number | PTH1-84 | Baseline | 1.74 | Standard Deviation 0.34 | mm^-1 |
| Trabecular Number | PTH1-84 | Year 2 | 2.07 | Standard Deviation 0.5 | mm^-1 |
| Cortical Porosity | PTH1-84 | Baseline | 7.4 | Standard Deviation 3.2 | percentage of porosity |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PTH1-84 | 68 | |
| Overall Study | COMPLETED | PTH1-84 | 48 | |
| Overall Study | NOT COMPLETED | PTH1-84 | 20 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anxiety/Irritabilty/Stress | Psychiatric disorders | PTH1-84 | 20 | 68 | 29 |
| other | Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | PTH1-84 | 47 | 68 | 134 |
| other | Rash | Skin and subcutaneous tissue disorders | PTH1-84 | 5 | 68 | 5 |
| other | Bruising at injection site | Skin and subcutaneous tissue disorders | PTH1-84 | 9 | 68 | 9 |
| other | Chest Pain | Respiratory, thoracic and mediastinal disorders | PTH1-84 | 8 | 68 | 8 |
| other | Cold/Flu Virus/Symptoms | Infections and infestations | PTH1-84 | 28 | 68 | 32 |
| other | Constipation | Gastrointestinal disorders | PTH1-84 | 7 | 68 | 8 |
| other | Decrease in Urination | Renal and urinary disorders | PTH1-84 | 7 | 68 | 7 |
| other | Depression | Psychiatric disorders | PTH1-84 | 11 | 68 | 12 |
| other | Diarrhea | Gastrointestinal disorders | PTH1-84 | 9 | 68 | 9 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PTH1-84 | ||
| Total, other adverse events | PTH1-84 | 68 | 68 |
| Total, serious adverse events | PTH1-84 | 15 | 68 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29972871 | DERIVED |
Source PubMed
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK069350 | Bone Properties in Hypoparathyroidism: Effects of PTH | BILEZIKIAN, JOHN P | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2005 to 2014 |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00473265
GET https://conductscience.org/api/trials/v1/NCT00473265/events?page=2