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

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ClinicalTrials.gov Identifier: NCT03292146
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Bone Density Bone Loss Anorexia Nervosa Eating Disorder Atypical Anorexia Nervosa Drug: Denosumab 60 MG [Prolia] Drug: Placebo Injection Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Active Denosumab 60mg Injection
Denosumab 60mg injection at baseline study visit and 6 month study visit.
Drug: Denosumab 60 MG [Prolia]
Denosumab 60mg injection at baseline and 6 months

Placebo Comparator: Placebo
Placebo injection at baseline study visit and 6 month study visit.
Drug: Placebo Injection
Placebo Injection at baseline and 6 months




Primary Outcome Measures :
  1. Change in bone density [ Time Frame: 6 months and 12 months ]
    Change in bone density



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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 24 months.
  • Known senstivity 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292146


Contacts
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Contact: Karen K Miller, MD 617-726-3870 KKMILLER@partners.org
Contact: Erinne Meenaghan, NP 617-724-7393 EMEENAGHAN@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Karen Miller, MD    617-726-3870    kkmiller@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Amgen
Investigators
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Principal Investigator: Karen K Miller, MD Massachusetts General Hospital

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Responsible Party: Karen Klahr Miller, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03292146     History of Changes
Other Study ID Numbers: 2017P000529
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs