Clinical Trial Details

NCT ID: NCT03292146
Date Last Changed: September 25, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Denosumab 60 MG [Prolia] and Placebo Injection

Research Study Title

Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study

Purpose

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.

To Learn more

Recruitment Details

Phase
Early 1
Gender
Female
Age
20 to 60 Years
Overall Status
Recruiting
Lead Sponsor
Massachusetts General Hospital
Duration
24 Months
Facility Type
N/A
Compensation

Eligibility

Female ages 20 Years to 60 Years

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

Site Locations (1)

Country State City Zip Facility and Contact
United States Massachusetts Boston 02114 Massachusetts General Hospital
Karen Miller, MD
617-726-3870
kkmiller@mgh.harvard.edu

Contact

Karen K Miller, MD
617-726-3870
E-mail:

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