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Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

Primary Purpose

Bone Density, Low, Bone Loss, Anorexia Nervosa

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Romosozumab Prefilled Syringe
Placebo
Alendronate 70Mg Tab
Sponsored by
Karen Klahr Miller, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Density, Low

Eligibility Criteria

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

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), intrauterine hormonal-releasing system (IUS), surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion), and woman's 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:

  • Body mass index (BMI) <17 kg/m2
  • Hospitalization within 3 months of baseline study visit, including inpatient eating disorder treatment facility; participating in a residential eating disorder treatment program within 3 months of study participation is permitted
  • Myocardial infarction or stroke within 1 year preceding enrollment
  • 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 25-OH vitamin D level <30 ng/mL
  • Serum potassium <3.0 meq/L
  • Serum magnesium <1.5 meq/L
  • Serum ALT >3 times upper limit of normal
  • eGFR of less than 30 ml/min
  • LDL > 190 mg/dL
  • 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 sensitivity to any of the products or components of the medication to be administered
  • Sensitivity to calcium or vitamin D supplements
  • Pregnant, planning to become pregnant within 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 Romosozumab 210mg Injection

Placebo

Arm Description

Romosozumab 210mg injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Placebo injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Outcomes

Primary Outcome Measures

Change in bone density
Change in bone density

Secondary Outcome Measures

Change in bone density
Change in bone density

Full Information

First Posted
February 26, 2021
Last Updated
October 1, 2023
Sponsor
Karen Klahr Miller, MD
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04779216
Brief Title
Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa
Official Title
Effects of Romosozumab on Bone 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
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Klahr Miller, MD
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 romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone formation and decrease in markers of bone resorption, and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo. The extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) 70 mg once weekly after the initial 12 month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab 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 romosozumab followed by 12 months of alendronate, the investigators 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, Low, Bone Loss, Anorexia Nervosa, Eating Disorders

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 Romosozumab 210mg Injection
Arm Type
Experimental
Arm Description
Romosozumab 210mg injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Intervention Type
Drug
Intervention Name(s)
Romosozumab Prefilled Syringe
Intervention Description
Romosozumab 210mg Injection monthly for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Injection monthly for 12 months
Intervention Type
Drug
Intervention Name(s)
Alendronate 70Mg Tab
Intervention Description
Alendronate 70mg PO weekly starting at 12 months through 24 months.
Primary Outcome Measure Information:
Title
Change in bone density
Description
Change in bone density
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in bone density
Description
Change in bone density
Time Frame
6 months, 24 months

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 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), intrauterine hormonal-releasing system (IUS), surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion), and woman's 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: Body mass index (BMI) <17 kg/m2 Hospitalization within 3 months of baseline study visit, including inpatient eating disorder treatment facility; participating in a residential eating disorder treatment program within 3 months of study participation is permitted Myocardial infarction or stroke within 1 year preceding enrollment 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 25-OH vitamin D level <30 ng/mL Serum potassium <3.0 meq/L Serum magnesium <1.5 meq/L Serum ALT >3 times upper limit of normal eGFR of less than 30 ml/min LDL > 190 mg/dL 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 sensitivity to any of the products or components of the medication to be administered Sensitivity to calcium or vitamin D supplements Pregnant, planning to become pregnant within 7 months after the end of treatment, and/or breastfeeding
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

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