UnknownPhase 4

Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

China300 participantsStarted 2023-09-27

Plain-language summary

To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.

Who can participate

Age range

50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Postmenopausal women (based on medical history) aged 50 or older and menopause time more than 2 years. If there is uncertainty regarding menopausal status, women 60 years of age and older will be considered postmenopausal.
. BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening:

Exclusion criteria

. Severe vitamin D deficiency at screening (defined as serum 25OHD\<10 ng/ml);Vitamin D repletion will be permitted and dosage will be at the discretion of investigators and subjects may be re-screened
. Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlled diabetes mellitus (HbA1c\>9%), or other conditions that can cause secondary osteoporosis, or treatment with glucocorticoids in the 2 months prior to study entry

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine

Timeframe: Baseline to 12 months

Trial details

NCT IDNCT05902078

SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Li Shen

(+86)15800674978 shenli_0510@126.com

View on ClinicalTrials.gov More Low Bone Mineral Density trials