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NCT03994172ACTIVE_NOT_RECRUITINGanonymous

Novel Combination Therapy for Osteoporosis in Men

Sponsor

Source record

VA Office of Research and Development

Phase

Source record

PHASE4

Modality

AI-normalized

small molecule

Target

AI-normalized

Teriparatide or human parathyroid hormone (PTH) 1-34, Cinacalcet, placebo tablet, Calcium citrate tablet, Vitamin D3

Indication / condition

AI-normalized

Male Osteoporosis

Intervention

Source record

Teriparatide or human parathyroid hormone (PTH) 1-34, Cinacalcet, placebo tablet, Calcium citrate tablet, Vitamin D3

Source & freshness

Source record

NCT ID

NCT03994172

Original source

ClinicalTrials.gov

Source last updated

Jul 31, 2025

Ingested at

Jun 18, 2026

Internal sync

Jun 18, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT03994172

Title

Novel Combination Therapy for Osteoporosis in Men

Sponsor

VA Office of Research and Development

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE4

Condition raw

Male Osteoporosis

Condition normalized

Male Osteoporosis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Teriparatide or human parathyroid hormone (PTH) 1-34, Cinacalcet, placebo tablet, Calcium citrate tablet, Vitamin D3

Target normalized

Teriparatide or human parathyroid hormone (PTH) 1-34, Cinacalcet, placebo tablet, Calcium citrate tablet, Vitamin D3

Interventions

Teriparatide or human parathyroid hormone (PTH) 1-34, Cinacalcet, placebo tablet, Calcium citrate tablet, Vitamin D3

Public preview

Source record

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 understand whether an effective combination therapy in mice will prove to be effective in men.

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