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IGF-1 and Bone Loss in Women With Anorexia Nervosa

IGF-1 and Bone Loss in Women With Anorexia Nervosa

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01406444
Enrollment
148
Registered
2011-08-01
Start date
2011-10-31
Completion date
2019-05-31
Last updated
2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Osteopenia, Osteoporosis

Keywords

Anorexia Nervosa, Osteopenia, Osteoporosis, Bone density

Brief summary

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

DRUGrhIGF-1

Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.

DRUGRisedronate

Risedronate 35mg PO one time weekly

DRUGPlacebo

Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postero-anterior Spine Bone Mineral Density by DXA12 MonthsPostero-anterior spine bone mineral density by dual-energy X-ray absorptiometry

Secondary

MeasureTime frameDescription
Lateral Spine Bone Mineral Density by DXA12 MonthsLateral spine bone mineral density by dual-energy X-ray absorptiometry

Countries

United States

Participant flow

Pre-assignment details

148 subjects were consented and screened, 90 subjects were randomized, and 82 subjects completed the baseline visit. Of the 90 who were randomized, 8 subjects did not attend their scheduled baseline visits and did not receive study medication.

Participants by arm

ArmCount
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
33
Risedronate
Risedronate 35mg PO once weekly for 12 months
33
Placebo
Placebo for 12 months
16
Total82

Baseline characteristics

CharacteristicTotalPlaceboRisedronaterhIGF-1 Followed by Risedronate
Age, Continuous27.5 years
STANDARD_DEVIATION 6.7
25.4 years
STANDARD_DEVIATION 6.3
28.1 years
STANDARD_DEVIATION 7.1
27.9 years
STANDARD_DEVIATION 6.5
Body mass index18.4 kg/m2
STANDARD_DEVIATION 1.8
18.6 kg/m2
STANDARD_DEVIATION 1.7
18.4 kg/m2
STANDARD_DEVIATION 2.2
18.4 kg/m2
STANDARD_DEVIATION 1.5
Lateral spine bone mineral density0.67 g/cm2
STANDARD_DEVIATION 0.09
0.67 g/cm2
STANDARD_DEVIATION 0.07
0.66 g/cm2
STANDARD_DEVIATION 0.09
0.67 g/cm2
STANDARD_DEVIATION 0.09
Postero-anterior spine bone mineral density0.88 g/cm2
STANDARD_DEVIATION 0.12
0.88 g/cm2
STANDARD_DEVIATION 0.12
0.86 g/cm2
STANDARD_DEVIATION 0.12
0.88 g/cm2
STANDARD_DEVIATION 0.12
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
2 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
White
76 Participants14 Participants32 Participants30 Participants
Sex: Female, Male
Female
82 Participants16 Participants33 Participants33 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 330 / 16
other
Total, other adverse events
19 / 3318 / 335 / 16
serious
Total, serious adverse events
0 / 330 / 330 / 16

Outcome results

Primary

Postero-anterior Spine Bone Mineral Density by DXA

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

Time frame: 12 Months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
rhIGF-1 Followed by RisedronatePostero-anterior Spine Bone Mineral Density by DXA0.891 g/cm2Standard Error 0.014
RisedronatePostero-anterior Spine Bone Mineral Density by DXA0.887 g/cm2Standard Error 0.014
PlaceboPostero-anterior Spine Bone Mineral Density by DXA0.874 g/cm2Standard Error 0.013
p-value: 0.03Linear random effects model
Secondary

Lateral Spine Bone Mineral Density by DXA

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

Time frame: 12 Months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
rhIGF-1 Followed by RisedronateLateral Spine Bone Mineral Density by DXA0.695 g/cm2Standard Error 0.012
RisedronateLateral Spine Bone Mineral Density by DXA0.677 g/cm2Standard Error 0.012
PlaceboLateral Spine Bone Mineral Density by DXA0.666 g/cm2Standard Error 0.01
p-value: 0.002Linear random effects model
p-value: 0.04Linear random effects model

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026