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

Primary Purpose

Bone Density, Bone Loss, Anorexia Nervosa

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Denosumab 60 MG [Prolia]
Placebo Injection
Alendronate 70Mg Tab
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Density

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Denosumab 60mg Injection

Placebo

Arm Description

Denosumab 60mg injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Placebo injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Outcomes

Primary Outcome Measures

Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)
Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA).

Secondary Outcome Measures

Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA

Full Information

First Posted
September 21, 2017
Last Updated
September 19, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03292146
Brief Title
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
Official Title
Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
July 22, 2021 (Actual)
Study Completion Date
July 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Density, Bone Loss, Anorexia Nervosa, Eating Disorder, Atypical Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Denosumab 60mg Injection
Arm Type
Experimental
Arm Description
Denosumab 60mg injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Intervention Type
Drug
Intervention Name(s)
Denosumab 60 MG [Prolia]
Intervention Description
Denosumab 60mg injection at baseline and 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo Injection
Intervention Description
Placebo Injection at baseline and 6 months
Intervention Type
Drug
Intervention Name(s)
Alendronate 70Mg Tab
Intervention Description
Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Primary Outcome Measure Information:
Title
Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)
Description
Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA).
Time Frame
12 months (Period 1)
Secondary Outcome Measure Information:
Title
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
Time Frame
Baseline to 24 months
Title
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
Time Frame
12 months to 24 months (Period 2)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen K Miller, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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