The effect of leptin replacement on parathyroid hormone, RANKL-osteoprotegerin axis, and Wnt inhibitors in young women with hypothalamic amenorrhea

What Was Tested

This randomized controlled trial paper looks at Parathyroid Hormone (PTH 1-84).

The objective of the study was to investigate how metreleptin exerts its positive effect on bone metabolism in humans.

Why It Was Studied

Recombinant leptin (metreleptin) treatment restores bone mineral density in women with hypothalamic amenorrhea (HA), a condition characterized by hypoleptinemia, which has adverse impact on bone health.

Who Took Part

By PubMed's age tags, the people studied were teenagers, young adults and adults, women only.

Women (n = 18) with HA and hypoleptinemia for at least 6 months were randomized to receive either metreleptin or placebo for 36 weeks.

Serum samples were obtained at baseline and 12, 24, and 36 weeks of treatment.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

The participants were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Parathyroid Hormone (PTH 1-84).

The comparison arm used a placebo, so changes seen with Parathyroid Hormone (PTH 1-84) could be set against what happens without it.

The timeline in the abstract includes 36 weeks.

This was a randomized, double-blinded, placebo-controlled study.

The study was conducted at Beth Israel Deaconess Medical Center (Boston, Massachusetts).

What Was Measured

Topics PubMed links to this paper include Adaptor Proteins, Signal Transducing, Amenorrhea, Bone Morphogenetic Proteins, Fibroblast Growth Factor-23, Fibroblast Growth Factors, Genetic Markers and Hormone Replacement Therapy.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Parathyroid Hormone (PTH 1-84) over 36 weeks.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2014 (The Journal of clinical endocrinology and metabolism), a journal based in United States.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.