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Trial · Interventional

CompletedNot applicableResults postedRegistry data

IGF-1 and Bone Loss in Women With Anorexia Nervosa

NCTNCT01406444 (opens ClinicalTrials.gov in a new tab)Other id2R01DK052625
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Overview

Status
Completed
Phase
Not applicable
Enrollment
148 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Oct 2011
Primary completion
May 2019
Completion
May 2019
First posted
1 Aug 2011 (estimated)
Last update posted
17 Jul 2020
Conditions
Anorexia Nervosa · Osteopenia · Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122014201620182020
  1. N/A

    IGF-1 and Bone Loss in Women With Anorexia Nervosa

    NCT01406444

    Oct 2011 to May 2019

Registry summary

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

Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). A significant decrease in bone density is called osteopenia or osteoporosis. Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this condition often have thin or weak bones that are more likely to break. They also have very low levels of a chemical called IGF-1 in their body. This chemical is very important for increasing bone growth in puberty and for maintaining healthy adult bones. The investigators would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can lead to an increase in bone formation, bone density, and bone strength in women with anorexia nervosa.

Interventions

  • rhIGF-1Drug
  • RisedronateDrug
  • PlaceboDrug

Arms3

  • Active comparator

    rhIGF-1 followed by Risedronate

    Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly

  • Active comparator

    Risedronate

    Risedronate 35mg PO once weekly for 12 months

  • Placebo comparator

    Placebo

    Placebo for 12 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Postero-anterior Spine Bone Mineral Density by DXA

    Time frame · 12 Months

    Registry description

    Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry

Secondary outcomes(1)

  1. Lateral Spine Bone Mineral Density by DXA

    Time frame · 12 Months

    Registry description

    Lateral spine bone mineral density by dual-energy X-ray absorptiometry

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 outcomeLeast squares mean· 12 Months

Postero-anterior Spine Bone Mineral Density by DXA

GroupValue (g/cm2)Spread
rhIGF-1 Followed by Risedronate0.8910.014
Risedronate0.8870.014
Placebo0.8740.013
Secondary and other outcome results(1)
Secondary outcomeLeast squares mean· 12 Months

Lateral Spine Bone Mineral Density by DXA

GroupValue (g/cm2)Spread
rhIGF-1 Followed by Risedronate0.6950.012
Risedronate0.6770.012
Placebo0.6660.010

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
rhIGF-1 Followed by RisedronateSequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly0 / 330 / 3319 / 33
RisedronateRisedronate 35mg PO once weekly for 12 months0 / 330 / 3318 / 33
PlaceboPlacebo for 12 months0 / 160 / 165 / 16

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.

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: * Age 18-45 years * AN defined by DSM-IV diagnostic criteria, including weight less than 85% of ideal body weight (restricting or binge/purge type, BMI 15-17.5) OR meet criteria for sub-threshold AN, i.e., all DSM-IV criteria except that patients can have a BMI of \<18.5 kg/m2 with or without amenorrhea * 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 * Ongoing care from a primary care provider * Agree to use barrier contraception Exclusion Criteria: * Any subject with contraindications to risedronate * Any subject with binge-purge subtype of anorexia nervosa who vomits regularly as their form of purging (vs. those who use laxatives or diuretics) and who have significant periodontal disease, tooth erosion or an invasive dental or periodontal procedure within the previous three months. * Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure * Any medication known to affect bone metabolism within 3 months of the study, excluding oral contraceptives. Bisphosphonates must have been discontinued for at least one year before participation * Serum potassium \<3.0 meq/L * Serum ALT \>3 times upper limit of normal * eGFR of less than 30 ml/min * Pregnant and/or breastfeeding * Diabetes mellitus * Active substance abuse, including alcohol * History of malignancy * Atraumatic fracture within the prior year

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