Health TrialsbyHealthPanel

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

ConditionFHA (Functional Hypothalamic Amenorrhea)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age14-30
SponsorMassachusetts General Hospital

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, age 14-30 years, skeletally mature with bone age ≥ 12 years

an effective non-hormonal contraceptive method

a progestin releasing intrauterine device (no evidence of systemic skeletal effects)

a progestin releasing implant

Disqualifiers

Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus

Use of bisphosphonates in the past year

Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation).

Current use of systemic corticosteroids

Trial design

Design model

Parallel

Treatments tested in this trial

  • Romosozumab

    Drug

    Six monthly subcutaneous injections. This group will also receive a 100-microgram transdermal estradiol patch applied twice weekly, and 200 mg of oral progesterone for the first 12 days of each month.

  • Placebo

    Drug

    Identical to romosozumab but inactive. This group will also receive a 100-microgram transdermal estradiol patch applied twice weekly, and 200 mg of oral progesterone for the first 12 days of each month.

  • Zoledronic acid

    Drug

    One intravenous infusion

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: RomosozumabExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Group C: Healthy ControlsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Lumbar spine bone density

6-month change in lumbar spine bone density

Time frame
0 and 6 months
2

Tibial cortical thickness

6-month change in tibial cortical thickness

Time frame
0 and 6 months
3

Tibial failure load

6-month change in tibial failure load

Time frame
0 and 6 months

Secondary outcomes

1

Femoral neck and total hip bone density

6- and 12-month change in femoral neck and total hip bone density

Time frame
0, 6, and 12 months
2

Lumbar spine bone density

12-month change in lumbar spine bone density

Time frame
0 and 12 months
3

Radial cortical thickness

6- and 12-month change in radial cortical thickness

Time frame
0, 6, and 12 months
4

Tibial cortical thickness

12-month change in tibial cortical thickness

Time frame
0 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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