PRE-GAiN Bone Health Pilot Study

Sponsor
University of Saskatchewan
Study ID
NCT04021017
Phase
PHASE1
Status
Withdrawn

Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Estradiol Hemihydrate Transdermal System — DRUG
    Participants who have had their first period or have a bone age greater than or equal to 14 years will receive PrClimara® 25 (estradiol hemihydrate transdermal system - 25 mcg/day) as a weekly patch, for 24 months. Participants who have not yet had their first period and have a bone age below 14 years will receive an increasing dose of estrogen. These participants will be initiated on graduated dose of transdermal 17-β estradiol patches: 3.1 mcg/day (1/8 patch) for first six-months, 6.2 mcg/day (1/4 patch) for second six-months, 12.5 mcg/day (1/2 patch) for third six-months and 25 mcg/day (full patch) for final six-months.

Study Details

This study will assess the affects of an estradiol hemihydrate transdermal system on bone health in 24 adolescent females aged 12-19 years old with anorexia nervosa. Participants in this study will be randomized 1:1 into 2 groups. One group will receive treatment with a transdermal estrogen patch and the other group will not.

Key Dates

Start date
Jan 21, 2020
Status verified
Dec 2022
Primary completion
Dec 13, 2022
Completion
Dec 13, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Participants randomized to the treatment arm will be divided by maturational status: * Participants who have had their first period or have a bone age greater than or equal to 14 years will receive PrClimara® 25 (estradiol hemihydrate transdermal system - 25 mcg/day) as a weekly patch, for 24 months. o These participants will also receive progesterone (Provera 10 mg tablet) orally every 4 weeks, for 7 days during the second half of the planned menstrual cycle, in order to induce a menstrual period. * Participants who have not yet had their first period and have a bone age below 14 years will receive an increasing dose of estrogen. These participants will be initiated on graduated dose of transdermal 17-β estradiol patches: * 3.1 mcg/day (1/8 patch) for first six-months, * 6.2 mcg/day (1/4 patch) for second six-months, * 12.5 mcg/day (1/2 patch) for third six-months, and * 25 mcg/day (full patch) for final six-months.
  • No Intervention: No Treatment
    The participants in this group will not receive the estrogen patch nor the oral progesterone.

Primary Outcome Measure

Cortical Wall Thickness [ Time Frame: Change from Baseline to Month 24 ]

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