Effect of alendronate and MK-677 (a growth hormone secretagogue), individually and in combination, on markers of bone turnover and bone mineral density in postmenopausal osteoporotic women

What Was Tested

The paper reports a study of MK-677 (Ibutamoren) in the context of osteoporosis and bone density, published as a randomized controlled trial.

The researchers hypothesized that administration of MK-677, an orally active GH secretagogue, together with alendronate, a potent inhibitor of bone resorption, would maintain a higher bone formation rate relative to that seen with alendronate alone, thereby generating greater enhancement of bone mineral density (BMD) in women with postmenopausal osteoporosis.

The researchers determined the individual and combined effects of MK-677 and alendronate administration on insulin-like growth factor I levels and biochemical markers of bone formation (osteocalcin and bone-specific alkaline phosphatase) and resorption [urinary N-telopeptide cross-links (NTx)] for 12 months and BMD for 18 months.

Who Took Part

The study group was 292 women.

By PubMed's age tags, the people studied were middle-aged adults and older adults, women only.

How the Study Was Run

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

Because people in this MK-677 (Ibutamoren) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the women and researchers unaware of who received MK-677 (Ibutamoren).

The comparison arm used a placebo, so changes seen with MK-677 (Ibutamoren) could be set against what happens without it.

Running at several centres spread the MK-677 (Ibutamoren) study over different clinics and patient groups.

The timeline in the abstract includes 12 months.

What Was Measured

The researchers determined the individual and combined effects of MK-677 and alendronate administration on insulin-like growth factor I levels and biochemical markers of bone formation (osteocalcin and bone-specific alkaline phosphatase) and resorption [urinary N-telopeptide cross-links (NTx)] for 12 months and BMD for 18 months.

The primary results, except for BMD, are provided for month 12.

Topics PubMed links to this paper include Alendronate, Alkaline Phosphatase, Biomarkers, Bone Density, Bone Remodeling, Bone and Bones and Collagen.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of MK-677 (Ibutamoren) in 292 women in people with osteoporosis and bone density over 12 months.

The publication is from 2001 (The Journal of clinical endocrinology and metabolism), a journal based in United States.

More context: the MK-677 (Ibutamoren) compound page, Osteoporosis and bone density research.