Romosozumab for Amenorrhea

Recruiting at 1 trial location

Overseen By Melanie Haines, MD

Age: < 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Massachusetts General Hospital

Must be taking: Calcium, Vitamin D

Must not be taking: Bisphosphonates, Immunosuppressants

Disqualifiers: Diabetes, Hypertension, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

114 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires that participants do not use medications known to affect bone metabolism within 3 months of the study, except for calcium and vitamin D supplements. If you are taking such medications, you may need to stop them before joining the trial.

Eligibility Criteria

This trial is for girls and women aged 14-25 with functional hypothalamic amenorrhea, which means their periods stopped due to stress, exercise, or eating disorders. They should have low bone density but otherwise be healthy with normal blood tests and a recent dental check-up. Participants must not be pregnant and agree to use certain contraceptives.

Inclusion Criteria

I have had fewer than 3 periods in the last 6 months.

My pregnancy test is negative.

My thyroid, prolactin, potassium, and magnesium levels are normal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive romosozumab or placebo for 6 months, along with transdermal estradiol and cyclic progesterone. An IV infusion of zoledronate is administered at the 6-month visit.

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for changes in bone density and other outcomes at 12 months.

6 months

1 visit (in-person) at 12 months

Treatment Details

Interventions

• Romosozumab

Trial Overview The study tests if romosozumab can improve bone density in participants compared to a placebo over six months. Everyone gets an IV infusion of zoledronate at six months plus hormone therapy throughout the year. The aim is to see if those on romosozumab show better bone health after one year than those on placebo.

Participant Groups

Group I: Romosozumab Experimental Treatment 2 Interventions

Participants with functional hypothalamic amenorrhea randomized to romosozumab.

Group II: Healthy Controls Active Control 1 Intervention

Healthy controls (girls and women with regular menstrual periods)

Group III: Placebo Placebo Group 2 Interventions

Participants with functional hypothalamic amenorrhea randomized to placebo.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+