Can a drug duo rebuild bone in men better than one?
NCT ID NCT03994172
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests whether combining two bone-building drugs, teriparatide and cinacalcet, works better than teriparatide alone for men with low bone mass. Researchers will give one group the combination and another group teriparatide plus a placebo for 11 months. They will measure changes in bone density and markers of bone formation to see if the combination boosts bone more effectively.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- teriparatide (a bone-building drug) combined with cinacalcet (a drug that activates calcium receptors)
- What this could lead to
- If the combination works, it could offer a more effective way to treat osteoporosis in men, potentially reducing fracture risk.
- What could go wrong
- This is a small, early-stage trial in 40 men, and results in mice may not translate to humans. The combination may not improve bone density more than teriparatide alone, and side effects are possible.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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40 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jun 2025
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 85 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * DXA BMD T-score \< or = -2.0 at either lumbar spine (LS), femoral neck (FN) or total hip (TH) sites; or DXA BMD T-score \< or = -1.5 with at least one additional important clinical risk factor for osteoporotic fracture \[e.g., fragility fracture after age 50 years; parental history of hip fracture; history of hypogonadism, prior glucocorticoid therapy (\>3 months prior), current smoking, prevalent vertebral fracture(s), or prior hyperthyroidism on stable treatment\] * At least 2 LS vertebral levels with reliable BMD values (i.e., at least 2 without compression or hardware) Exclusion Criteria: * Metabolic bone disease other than osteoporosis (e.g., Paget's disease, hyperparathyroidism) * Any osteoporosis drug therapy within 12 months; any prior course of TPTD for \> or = 3 months; any history of IV bisphosphonate therapy; oral bisphosphonate therapy exceeding 3 months in past 2 years; oral bisphosphonate treatment exceeding 2 years ever; or use of denosumab (within the past 3 years or \> 3 or = injections ever). * Oral glucocorticoid use (\> or = 5 mg prednisone) taken within 3 months prior to enrollment * Hypercalcemia (albumin-corrected serum \[Ca\] \>10.2 mg/dL), hypocalcemia (albumin-corrected serum \[Ca\] \<8.8 mg/dL), elevated intact PTH level, or hypercalciuria (urinary Ca \>300 mg/24 hours) at screening * 25 OH vitamin D levels \<20 ng/ml or \>80 ng/ml at screening * Estimated glomerular filtration rate \< 30 ml/min (chronic kidney disease (CKD) stage 4 or 5) * Cancer within past 5 years except for non-melanomatous skin cancers * History of skeletal radiation, prior history of osteosarcoma or bone metastases * Substance abuse (\>3 drinks/day), liver disease or impaired liver function (abnormal liver function tests defined as greater than 3 times the upper limit of normal), known cirrhosis, malabsorption * Poorly controlled diabetes (A1c \>9.0%) or current thiazolidinedione therapy * Drugs metabolized through CYP2D6 (e.g., flecainide, tricyclic antidepressants) and strong inducers or inhibitors of CYP3A4 (e.g., itraconazole, ketoconazole) * Testosterone therapy with dose change within last 12 months; or androgen deprivation therapy within 12 months * Thyrotropin (TSH) level \< 0.01 * Congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other conditions that predispose to QT interval prolongation and ventricular arrhythmia * Hypersensitivity to teriparatide or any excipients in Forteo * Use of other Ca-lowering drugs (e.g., calcitonin, bisphosphonates, denosumab) * Moderate to severe hepatic impairment * High risk for active urolithiasis, defined as having passed a kidney stone clinically within the last 5 years * Upper gastrointestinal (GI) bleeding with a history of a clinical episode of upper GI bleeding within last 10 years that was note definitively treated by a surgical procedure * Orthostatic hypotension or a known history of orthostatic hypotension documented in the chart or provided by the patient upon clinical history-taking * Impaired cardiac function either diagnosed symptomatic heart failure requiring medical therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563, United States
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