Vitamin d derivative may help keep bones strong after menopause
NCT ID NCT07660536
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 3 times
Summary
This trial investigates whether doxercalciferol, a form of vitamin D, can prevent bone loss in the spine and thigh bone in postmenopausal women with low bone density. Participants take either doxercalciferol or a placebo daily for two years, with bone density measured at the start, 12 months, and 24 months. The goal is to see if this drug can help maintain bone strength and reduce fracture risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- doxercalciferol
- What this could lead to
- If it works, this could point toward a non-hormonal option to slow bone loss and reduce fracture risk in postmenopausal women.
- What could go wrong
- This is a small, early-to-mid-stage trial. The drug may not improve bone density more than placebo, and side effects like elevated calcium levels 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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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60 people
The number who actually took part.
- Started
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Nov 1989
- Finished
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Dec 1994
- 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
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60 to 78 years
- 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: * postmenopausal women, age 60-78 years * normal general laboratory tests * serum calcium \>10.6 mg/dl (2.65 mmol/L ) or \>0.3 mg/dl (0.075mmol/L) above upper limit of normal on 2 baseline tests, * 24-hour urine calcium \< 300mg (7.5mmol) on two baseline tests, * Bone mineral density (BMD) measured by DEXA of the spine vertebrae L2-3 of 0.70-1.05 g/cm2 Exclusion criteria : * no significant medical disorder known to affect calcium or bone metabolism- hypercalcemia, active renal stone disease ( more than 1 stone episode/ year) or more than 2 stone episodes in a lifetime, sarcoidosis * severe chronic illness, chronic renal failure ( serum creatinine \>1.4mg/dl ,chronic heart failure, * any terminal illness * any history of cancer (except skin cancer) within the last 10 years, * uncontrolled diabetes with significant proteinuria or fasting blood sugar \> 140mg/dl * alcoholism * prolonged hospitalization , extended immobilizations or arthritis that prevents normal physical activity, hemiplegia, previous hip fracture * no previous treatment with medication known to affect bone and calcium metabolism within the last year; chronic corticosteroid therapy \> 10mg/day thiazides, taking long term bisphosphonates or had them for more than 3 months in the past year, parathyroid hormone or derivatives in the last year, estrogen therapy within the last 6 months, anticonvulsants such as phenytoin ,high dose phenobarbital * BMI \> 45kg/m2
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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
-
Creighton University Medical center
Omaha, Nebraska, 68132, United States
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