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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether romosozumab, a medication for bone loss, can improve bone density in girls and women with functional hypothalamic amenorrhea. This condition, caused by intense exercise, stress, or eating disorders, stops periods and leads to low bone density. Participants will receive either romosozumab or a placebo for six months, followed by zoledronate and hormone treatments. The trial aims to determine if romosozumab improves bone density more effectively after a year compared to the placebo and to compare these results with healthy women who have regular periods. The trial seeks females aged 14-30 who have had fewer than three periods in the last six months and have low bone density. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that romosozumab is generally safe for people. In earlier studies, some participants experienced mild side effects, such as headaches and joint pain, while serious side effects were rare.

The FDA has approved romosozumab for treating osteoporosis, confirming its safety for bone-related issues. The trial's late stage indicates that earlier research has proven romosozumab's safety.

Overall, while romosozumab might cause some mild side effects, it is considered safe for improving bone strength in similar conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for amenorrhea?

Unlike the standard treatments for amenorrhea, which often focus on hormonal therapies like estrogen replacement, Romosozumab offers a novel approach. Romosozumab is unique because it targets the sclerostin protein, which plays a role in bone formation. This mechanism not only helps with bone health but may also impact menstrual regularity indirectly by addressing underlying bone-related factors associated with amenorrhea. Researchers are excited about Romosozumab because it could provide a dual benefit: supporting bone density while potentially restoring menstrual cycles.

What evidence suggests that romosozumab might be an effective treatment for amenorrhea?

Studies have shown that romosozumab can increase bone density, which is crucial for individuals with low bone density due to functional hypothalamic amenorrhea. This condition stops menstrual periods because of factors like intense exercise or stress. Research indicates that romosozumab aids bone growth and reduces bone loss. In previous studies, patients taking romosozumab experienced improvements in bone mineral content, a key measure of bone strength. In this trial, participants with functional hypothalamic amenorrhea will be randomized to receive either romosozumab or a placebo. These findings suggest that romosozumab could improve bone health for those with this condition, even though overall bone density improvements compared to a placebo weren't always observed. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06533865

Study: Romosozumab & Estrogen in Hypothalamic Amenorrhea The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06533865?cond=%22Amenorrhea%22&intr=%22estrogens%22&viewType=Table&rank=8

Romosozumab as an Adjunct to Physiologic Estrogen ... Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea. ClinicalTrials.gov ID NCT06533865.

3. uvaphysicianresource.com uvaphysicianresource.com/researcher-spotlight-madhusmita-misra/

Researcher Spotlight: Helping Children Develop Healthy Bones The study will enroll young women who are amenorrheic because of anorexia nervosa or excessive exercise. Participants will receive romosozumab ( ...

4. clinconnect.io clinconnect.io/trials/NCT06533865

Romosozumab as an Adjunct to Physiologic Estrogen The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9355702/

Functional hypothalamic amenorrhea: Impact on bone and ... Improved menstrual function but no difference in spine, hip, radius or total BMD in the treated vs. placebo groups (though bone mineral content increased in the ...

6. uvahealth.com uvahealth.com/clinical-trials/trial/302059

Romosozumab as an Adjunct to Physiologic Estrogen ... We are looking for young women who have had less than 3 menses in the preceding 6 months. This 12-month-long study involves 9 study visits at the University of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9251506/

Bone Perspectives in Functional Hypothalamic Amenorrhoea FHA has detrimental effects on the skeleton through disruption of normal skeletal homeostasis, ultimately resulting in an increased risk of fractures.

8. withpower.com withpower.com/trial/phase-3-fha-functional-hypothalamic-amenorrhea-9-2024-504a7

Romosozumab for Amenorrhea This Phase 3 medical study run by Massachusetts General Hospital is evaluating whether Romosozumab will have tolerable side effects & efficacy for patients ...