Romosozumab as an Adjunct to Physiologic Estrogen Replacement in 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

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

Treatments tested in this trial

  • Romosozumab
  • Placebo
  • Zoledronic acid

Treatment groups

114 Participants
are divided into 3 treatment groups

Sponsors and collaborators