RECRUITING

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea

Talk to us

Conditions

FHA (Functional Hypothalamic Amenorrhea)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation of the menstrual period due to intense exercise, stress, or an eating disorder) who have low bone density. Participants will be randomly assigned to receive romosozumab or placebo for 6 months. All participants will receive one IV infusion of zoledronate at the 6 month visit. All participants will also receive transdermal estradiol and cyclic progesterone. We will investigate whether participants who receive active romosozumab will demonstrate greater improvements in bone density at one year than those who receive placebo. We will also compare bone density over a year with healthy controls (girls and women of similar age who have regular menstrual periods).

Official Title

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults With Functional Hypothalamic Amenorrhea

Quick Facts

Study Start:2025-03-19
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06533865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 25 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female, age 14-25 years, skeletally mature with bone age ≥ 14 years (only 2% of growth left)
  2. * For women of reproductive age, agree to use an effective non-hormonal contraceptive method or a progestin releasing intrauterine device (no evidence of systemic skeletal effects) for the study duration
  3. * Biochemical criteria:
  4. * Negative βHCG (pregnancy test)
  5. * TSH, potassium, magnesium within the normal range; prolactin \<10 ng/mL above the upper limit of normal; FSH not elevated.
  6. * Serum ALT ≤ 3 times upper limit of normal, LDL ≤ 190 mg/dl
  7. * eGFR ≥ 30ml/minute
  8. * If the diagnosis of FHA is unclear, we may check additional labs (e.g., testosterone and sex hormone binding globulin if there is a suspicion of PCOS based on clinical hyperandrogenism).
  9. * Less than 3 menses in the preceding 6 months
  10. * BMD Z-score \< -1.0 at ≥ 1 skeletal site
  11. * Dental check-up within the past year
  1. * Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus
  2. * Use of bisphosphonates
  3. * Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation).
  4. * Migraine with aura.
  5. * Personal history of or first-degree relative with unprovoked thromboembolism (unless the subject has been tested and ruled out for a hypercoagulable state).
  6. * Active substance use disorder; current smoker
  7. * History of malignancy or Paget disease of bone
  8. * Pregnant, planning to become pregnant within 12 months after the end of treatment and/or breastfeeding
  9. * Cardiovascular: History of myocardial infarction or stroke; history of hypertension or use of anti-hypertensive medications
  10. * Immunodeficiency or taking immunosuppressive therapy
  11. * Other conditions that can cause oligo-amenorrhea such as PCOS, primary ovarian insufficiency
  12. * Dental: Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental procedures (tooth extraction, dental implants, oral surgery in the past 3 months), poor oral hygiene, periodontal and/or pre-existing dental disease, and current use of corticosteroids
  13. * Planned invasive dental procedure or other planned major surgery over the next 12 months (the duration of the study)
  14. * Known sensitivity or absolute contraindication to any of the products or components of the medications to be administered (romosozumab, zoledronic acid, transdermal estradiol, micronized progesterone, calcium or vitamin D supplements)
  15. * Concerning EKG findings for ischemia Additional exclusion criteria for normal-weight healthy controls
  16. * BMD Z-score \<-2.5 (who we will refer for evaluation)

Contacts and Locations

Study Contact

Karen K Miller, MD
CONTACT
617-726-3870
kkmiller@mgh.harvard.edu
Melanie Haines, MD
CONTACT
617-726-3897
mshaines@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-19
Study Completion Date2029-04

Study Record Updates

Study Start Date2025-03-19
Study Completion Date2029-04

Terms related to this study

Additional Relevant MeSH Terms

  • FHA (Functional Hypothalamic Amenorrhea)