Can a drug duo rebuild bone in men better than one?

NCT ID NCT03994172

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

40 people

The number who actually took part.

Started

Jul 2019

Finished

Jun 2025

Lead sponsor

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

60 to 85 years

Sex

Male participants only

Healthy volunteers

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

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

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California, 94121-1563, United States

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