Trial · NCT05666310
Muscle Impact of Treating Osteoporosis
NCT05666310, Phase 4, Completed, Nami Safai Haeri
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Muscle Impact of Treating Osteoporosis. Trials, record NCT05666310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05666310
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Muscle Impact of Treating Osteoporosis
- NCT number
- NCT05666310
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 20 participants, actual
- Lead sponsor
- Nami Safai Haeri
- Conditions
- Sarcopenia, Osteoporosis
- Interventions
- Denosumab, Zoledronic Acid, Denosumab Placebo, Zoledronic Acid Placebo
- First posted
- 2022-12-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Urinary D3-creatinine Enrichment (D3-creatine Dilution) | Baseline vs Month 12 | Muscle creatine pool size was estimated by D3-creatine dilution. Participants took a single 30 mg oral dose of deuterium-labeled creatine at baseline and 12 months, with a fasting morning urine sample collected approximately 72 hours later. Urinary D3-creatinine and total creatinine were measured by liquid chromatography-mass spectrometry. Enrichment is the " mol/mol ratio" of D3-creatinine to total creatinine in the same molar units, a dimensionless value from 0 to 1 (baseline values here were approximately 0.03, or 3%). Because about 95% of body creatine is in skeletal muscle, higher enrichment reflects less tracer dilution in a smaller pool and therefore less muscle mass. Reported values are the change (Month 12 minus Baseline), so a positive value is consistent with decreased muscle mass. Enrichment is reported rather than derived muscle mass because derived values showed high intra-individual variability. |
| Primary | Percentage Change From Baseline in Bone Mineral Density (BMD) | Baseline vs Month 12 | BMD is measured by a DXA scan system and a higher BMD is correlated with lower fracture risk |
| Primary | Change From Baseline in Appendicular Lean Mass. | Baseline vs Month 12 | Appendicular lean mass was measured by whole-body dual-energy X-ray absorptiometry and defined as the sum of lean soft tissue mass of both arms and both legs divided by height in meters squared "in kg/m²", excluding bone mineral content and fat mass. Values reported are the change (Month 12 minus Baseline) in appendicular lean mass index; a negative value indicates a decrease. |
| Primary | Change From Baseline in Grip Strength | Baseline vs Month 12 | Grip strength is measure of muscle strength and will be measured by a standard hand dynamometer |
| Primary | Change From Baseline in 4-Meter Walk Time (Gait Speed) | Baseline vs Month 12 | Gait speed is a measure of muscle function and will be measured by standard 4 meter gait speed test |
| Primary | Change From Baseline in Rectus Femoris Muscle Thickness (cm) | Baseline vs Month 12 | This variable will be measured by ultrasound |
| Primary | Change From Baseline in Rectus Femoris Muscle Cross-sectional Surface Area (cm²) | Baseline vs Month 12 | This variable will be measured by ultrasound |
| Primary | CTX Changes | Baseline vs Month 12 | Marker of bone resorption |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30AG024827 | Pittsburgh Older Americans Independence Center | BRACH, JENNIFER S | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE ON AGING | 2004 to 2025 |
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/NCT05666310
GET https://conductscience.org/api/trials/v1/NCT05666310/registered