Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study (NCT03292146) | Clinical Trial Compass
CompletedPhase 3
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
United States30 participantsStarted 2017-10-25
Plain-language summary
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators hypothesize that 12 months of denosumab administration will result in an increase in bone mineral density, decrease in markers of bone resorption and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo.
An optional extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) after the initial 12 month administration of denosumab or placebo. We hypothesize that 12 months of denosumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of denosumab followed by 12 months of alendronate, we hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.
Who can participate
Age range
20 Years – 60 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/Exclusion Criteria:
Inclusion Criteria:
* Female
* Age 20-60 years, skeletally mature with closed epiphyses
* Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria
* BMD T-score \< -1.0
* Normal serum 25-OH vitamin D (\>30 ng/mL) and calcium levels
* For women of reproductive age, agree to use an effective contraceptive method. Highly effective methods of birth control include:
* Combined (estrogen and progestogen) hormonal methods (pills, vaginal ring, or skin patch)
* Intrauterine device (IUD)
* Intraduterine hormonal-releasing system (IUS)
* Surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion)
* Your male partner has had a vasectomy and testing shows there is no sperm in the semen
* Dental check up within the past year
Exclusion Criteria:
* Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure
* Subjects with a known esophageal disease cannot participate in the alendronate extension study
* Any medication known to affect bone metabolism within 3 months of the study, excluding oral contraceptives or other forms of estrogen administration. Bisphosphonates must have been discontinued for at least one year before participation
* Immunodeficiency or taking immunosuppressive therapy
* Serum potassium \<3.0 meq/L
* Serum ALT \>3 times upper limit of normal
* eGFR of less than 30 ml/min
* Hypocalcemia
* Diabetes mellitus
* Active substance abuse, including alco…
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
1
Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)