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NCT03994172 · ClinicalTrials.gov registry record · Phase 4
Novel Combination Therapy for Osteoporosis in Men
A Phase 4 study of Male Osteoporosis, sponsored by VA Office of Research and Development.
- Active
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03994172 is a Phase 4 study of Male Osteoporosis that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03994172, a Phase 4 study of Male Osteoporosis, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Osteoporotic fractures are a key health problem in older men. Although there are drugs approved to treat osteoporosis in men \[bisphosphonates, denosumab, and teriparatide (TPTD) or PTH(1-34)\], there is a lack of knowledge on how to use them effectively. TPTD is a potent bone anabolic drug, meaning that it builds bone mass. However, doctors do not know if it should only be used as single drug or whether it can be more effectively combined to achieve the most benefit? This trial will test a novel combination therapy for osteoporosis in men based on exciting laboratory findings in mice. TPTD works to raise bone mass and improve bone strength by stimulating PTH receptors (PTH-Rs) on the membranes of bone-forming cells or osteoblasts (OBs). Calcimimetics are drugs that activate calcium receptors (CaSRs) in OBs. CaSRs in OBs participate in new bone formation. Daily injections of TPTD, given along with a calcimimetic drug (called NPS-R568), over 6 weeks markedly improved bone mineral density (BMD) and structure in mice. This study will test whether the combined activation of PTH-Rs and CaSRs (by the combination treatment of TPTD+calcimimetic cinacalcet) in men will produce greater bone forming responses than PTH-R activation alone (TPTD+placebo). The study has two aims and will be done in 48 men with low bone mass: (1) to determine the effects of 11 months treatment with TPTD+cinacalcet vs TPTD+placebo on BMD and bone metabolism by assessing lumbar spine BMD (primary endpoint), femoral neck BMD, and levels of the bone formation marker serum N-terminal pro-peptide of type 1 collagen; (2) to determine the biochemical responses by blood tests in men who receive the combination of TPTD+cinacalcet compared to men who get TPTD+placebo treatment. This is done by quantifying acute and chronic changes in serum calcium and PTH levels right after these drugs are given and how much calcium is excreted in the urine over time, with both treatment regimens. This study will help to unde
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Vitamin D3
- DRUG Teriparatide or human parathyroid hormone (PTH) 1-34
- DRUG Cinacalcet
- DRUG placebo tablet
- DIETARY_SUPPLEMENT Calcium citrate tablet
Study Locations (1)
California
- San Francisco VA Medical Center, San Francisco, CA - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03994172
The ClinicalTrials.gov registry entry for NCT03994172 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Male Osteoporosis appearing as the primary indexed condition, and to 5 interventions - of which Vitamin D3 is the first listed.
NCT03994172 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03994172 about?
NCT03994172 is a clinical study titled "Novel Combination Therapy for Osteoporosis in Men". Osteoporotic fractures are a key health problem in older men. Although there are drugs approved to treat osteoporosis in men \[bisphosphonates, denosumab, and teriparatide (TPTD) or PTH(1-34)\], there is a lack of knowledge on how to use them effectively. TPTD is a potent bone anabolic drug, meaning...
What is the current status of trial NCT03994172?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2019-07-01. Estimated completion is 2026-06-30.
What conditions does trial NCT03994172 study?
This clinical trial studies the following conditions: Male Osteoporosis.
What interventions are being tested in trial NCT03994172?
The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT), Teriparatide or human parathyroid hormone (PTH) 1-34 (DRUG), Cinacalcet (DRUG), placebo tablet (DRUG), Calcium citrate tablet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03994172?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03994172 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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