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
About this trial
This is an interventional treatment trial for Bone Density, Low
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
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
NCT ID
NCT04779216
First Posted
February 26, 2021
Last Updated
October 1, 2023
Sponsor
Karen Klahr Miller, MD
Collaborators
Amgen
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
We'll reach out to this number within 24 hrs