IGF-1 and Bone Loss in Women With Anorexia Nervosa

What Was Tested

This registered not phased trial tested IGF-1 LR3 for osteoporosis and bone density.

Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones.

It had three arms (groups): rhIGF-1 followed by Risedronate (active comparator), Risedronate (active comparator) and Placebo (placebo comparator).

Placebo for 12 months.

The registry classes the interventions as drug.

Who Took Part

The registry lists 148 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-45 years. Oral contraceptive use prior to enrollment. BMD T score \< -1.0. Normal FSH and TSH or free T4. Normal serum 25-OH vitamin D (\>20 ng/mL) and calcium levels.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: any subject with contraindications to risedronate; any disease known to affect bone, including untreated thyroid dysfunction, cushing's or renal failure; serum potassium \<3.0 meq/l.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this IGF-1 LR3 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The IGF-1 LR3 group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the osteoporosis and bone density participants and researchers unaware of who received IGF-1 LR3.

Those kept unaware of assignments: participant and investigator.

It started in 2011-10 with completion listed for 2019-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Postero-anterior Spine Bone Mineral Density by DXA (time frame: 12 Months).

It also tracked 1 secondary outcome, for example Lateral Spine Bone Mineral Density by DXA.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of IGF-1 LR3 in 148 people with osteoporosis and bone density.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the IGF-1 LR3 compound page, Osteoporosis and bone density research.