Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Bone Loss in Women With Anorexia Nervosa

NCTNCT00089843Other id5 R01 DK052625 (completed)Other idR01DK052625Other id1UL1RR025758

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names IGF-1 (mecasermin), does not test it. It appears in the title.

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 77 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Jun 2003
Primary completion: Apr 2008
Completion: Apr 2008
First posted: 17 Aug 2004 (estimated)
Last update posted: 2 Sept 2020
Conditions: Anorexia Nervosa

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2003200420052006200720082009

Ph 2/3
Bone Loss in Women With Anorexia Nervosa
NCT00089843
Jun 2003 to Apr 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Women with Anorexia Nervosa have been found to have low bone density. The study will determine whether administration of low doses of a natural hormone, testosterone and/or risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in this condition.

Interventions

TestosteroneDrug
Actonel (risedronate)Drug
Placebo Actonel (risedronate)Drug
Placebo testosteroneDrug

Arms4

Active comparator
2
Placebo Actonel (risedronate) and active testosterone patch
Active comparator
3
Active Actonel (risedronate) and active testosterone patch
Active comparator
4
Active Actonel (risedronate) and placebo testosterone
Placebo comparator
1
Placebo testosterone patch and placebo Actonel (risedronate)

Primary outcomes1

Outcomes the sponsor listed as primary.

Bone Mineral Density
Time frame · Baseline and 12 months
Registry description
Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change.

Secondary outcomes(1)

Markers of Bone Metabolism
Time frame · Baseline to 12 months
Registry description
type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 12 months

Bone Mineral Density

Group	Value (percent change)
Actonel (Risedronate) 35 mg Weekly	3.2
Testosterone	-0.6

Secondary and other outcome results(1)

Secondary outcomeMean· Baseline to 12 months

Markers of Bone Metabolism

Group	Value (percent change of CTX)
Actonel (Risedronate)	-41
Testosterone	-11

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Placebo Actonel and Active Testosterone PatchPlacebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)	–	6 / 19	12 / 19
Active Actonel and Active Testosterone PatchActive Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)	–	1 / 20	16 / 20
Active Actonel and Placebo TestosteroneActive Actonel tablet (35 mg weekly) and Placebo Testosterone Patch	–	5 / 20	16 / 20
Placebo Testosterone Patch and Placebo ActonelPlacebo Testosterone Patch and placebo Actonel tablet	–	2 / 18	12 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedMiller KK, Wexler TL, Zha AM, Lawson EA, Meenaghan EM, Misra M, Binstock AB, Herzog DB, Klibanski A. Androgen deficiency: association with increased anxiety and depression symptom severity in anorexia nervosa. J Clin Psychiatry. 2007 Jun;68(6):959-65. doi: 10.4088/jcp.v68n0621. PMID 17592924

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Anorexia Nervosa, * Over 18, * Female, * Decreased bone density Exclusion Criteria: * Medications to increase bone density

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