Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study

Description

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 6 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.

Study Start Date

October, 01 2017

Estimated Completion Date

April 2020

Interventions

  • Drug: Denosumab 60 MG [Prolia]
  • Drug: Placebo Injection

Study ID

Massachusetts General Hospital -- 2017P000529

Status

Recruiting

Trial ID

NCT03292146

Study Type

Interventional

Trial Phase

Early Phase 1

Enrollment Quota

75

Sponsor

Massachusetts General Hospital

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 (>20 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)
  • Intrauterine 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
  • 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 alcohol
  • History of malignancy
  • Paget disease of bone
  • Osteomalacia
  • Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease, and current use of corticosteroids
  • Planned invasive dental procedure over the next 6 months
  • Known sensitivity to any of the products or components to be administered during dosing or known sensitivity to mammalian cell derived drug products
  • Sensitivity to calcium or vitamin D supplements
  • Pregnant, planning to become pregnant with 7 months after the end of treatment and/or breastfeeding

Gender

Female

Ages

20 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Karen Miller MD 617-726-3870 kkmiller@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Karen Miller MD 617-726-3870 kkmiller@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Karen Miller MD 617-726-3870 kkmiller@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Karen Miller MD 617-726-3870 kkmiller@mgh.harvard.edu

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