Best way to switch osteoporosis meds after denosumab? small study tests timing
NCT ID NCT04177940
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at 45 people with osteoporosis caused by long-term steroid use. Participants had stopped taking denosumab and were switched to either zoledronic acid or alendronate at different times. The goal was to see which timing and drug best controlled bone loss markers. Results may guide future treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- denosumab, zoledronic acid, alendronate
- What this could lead to
- If successful, this could help doctors choose the best follow-up treatment to prevent bone loss after stopping denosumab in people on long-term steroids.
- What could go wrong
- This is a small pilot study with only 45 participants, so results may not apply to everyone. The study measures bone turnover markers, not actual fractures, so real-world benefits are uncertain.
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
-
45 people
The number who actually took part.
- Started
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Aug 2020
- Finished
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Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- 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 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: * Women and men, age 18 years or older and able to provide informed consent (IC) * ≥ 3 months of glucocorticoid use at \> 7.5 mg /day (prednisone equivalent dose) and anticipated to remain on glucocorticoids for at least six months * A baseline BMD T-score of ≤ -2.0 at the lumbar spine, total hip, or femoral neck; OR * A BMD T-score ≤ -1.0 at the lumbar spine, total hip, or femoral neck and a history of an osteoporotic fracture. Exclusion Criteria: * • Patients with fewer than three lumbar vertebrae that could be evaluated on dual energy x-ray absorptiometry (DXA) * Treatment with bisphosphonates in the preceding 2 years * Greater than 24 months (\>4 injections) of prior treatment with denosumab * Women of childbearing potential, who are not currently using birth control, are pregnant, planning to become pregnant, or are breastfeeding. For women of childbearing potential: refusal to use 2 highly effective forms of contraception and to continue this practice for 7 months after last injection of study medication\* * Men planning to conceive in the next 12 months * Unstable systemic medical condition * Uncontrolled hyperthyroidism * Uncontrolled hypothyroidism * History of Addison disease * History of osteomalacia * History of osteonecrosis of the jaw (ONJ) * History of atypical femur fracture * History of tooth extraction, jaw surgery, dental implants, or other dental surgery within the prior 6 months * History of anorexia nervosa, bulimia (by history or physical) or obvious malnutrition. * Invasive dental work(implants/surgery) planned in the next 2 years * History of Paget's disease of bone * Other bone diseases which affect bone metabolism * Vitamin D deficiency \[25(OH) vitamin D level \< 20 ng/mL (\<49.9 nmol/L)\] * Hypercalcemia \>10% above upper limit of normal (ULN) * Elevated transaminases or total bilirubin ≥ 2.0 x ULN * History of any solid organ or bone marrow transplant * Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma or localized squamous cell carcinoma of the skin) * Hypocalcemia \<10% below lower limit of normal (LLN) * Estimated glomerular filtration rate \< 30 mL/minute/1.73 m\^2 * Intolerance to calcium supplements, vitamin D supplements * Contraindication to, or poorly tolerant of denosumab therapy (including hypersensitivity to the drug) * Contraindication to, or poorly tolerant of zoledronic therapy (including hypersensitivity to the drug) * Contraindication to, or poorly tolerant of alendronate (including hypersensitivity to the drug and sever gastro-intestinal intolerance to oral bisphosphonates) * Recipient of an investigational drug within 4 weeks prior to study drug administration * Not a good candidate for study participation in opinion of investigator
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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
-
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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