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