New combo therapy may boost bone strength in older women
NCT ID NCT05884372
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether adding eldecalcitol (a vitamin D-like drug) to denosumab (a bone-strengthening shot) works better than denosumab with regular vitamin D for postmenopausal women with weak bones (osteoporosis). About 100 women took part for 12 months. The main goal was to see if the combination improved bone density more. This is a disease-control study because osteoporosis requires ongoing management.
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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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100 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Jul 2025
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female 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: * 1.Postmenopausal patients with osteoporosis, measured by dual energy X-ray absorptiometry (DXA), the T value of lumbar spine, femoral neck or total hip BMD is ≤-2.5, or with low mineral density (-2.5 \< T-score \< -1.0) plus a fragility fracture of the proximal humerus or distal forearm, or a history of vertebral compression fracture. * 2.Voluntarily participate in this study and sign the informed consent. Exclusion Criteria: * 1.Suffering from hyperthyroidism, Cushing's syndrome, hypogonadism, poorly controlled diabetes mellitus (glycated hemoglobin \[HbA1c\>9.0%\]), or other diseases that may lead to secondary osteoporosis. * 2.Patients who have received denosumab therapy before screening: received oral bisphosphonate treatment more than 3 years or received bisphosphonate treatment within 6 months before screening, or received treatment with glucocorticoids, vitamin K, active vitamin D compounds, selective estrogen receptor modulators, calcitonin, hormone replacement therapy, or teriparatide within the 8 weeks prior to study enrollment.. * 3.Patients who at screening have urinary tract stones detected on B-mode ultrasonography or who have a prior history of urolithiasis. * 4.Corrected serum calcium value at screening exceeds 2.6mmol/L (10.4mg/dL) or serum calcium value is lower than 2.12mmol/L(8 mg/dL) or hypercalciuria (\> 0.4 mg/dL GF), or chronic kidney disease (eGFR \< 30 mL/min/1.73 m2). * 5.Patients with a history of malignant tumors. * 6.Patients judged by investigators to be unsuitable as subjects.
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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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Zeng,Yuhong
Xi'an, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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