Musculoskeletal effects of the recombinant human IGF-I/IGF binding protein-3 complex in osteoporotic patients with proximal femoral fracture: a double-blind, placebo-controlled pilot study.

Boonen S, Rosen C, Bouillon R, Sommer A, McKay M, Rosen D, Adams S, Broos P, Lenaerts J, Raus J, Vanderschueren D, Geusens P

The Journal of clinical endocrinology and metabolism1 Apr 2002Cited by 74 (Europe PMC)

PMID11932288DOI10.1210/jcem.87.4.8426PepBankPUB-11932288

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone7

In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking IGF-1 (mecasermin).

01HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialSafety outcome
In older women with hip fracture, neither complex dose produced observed hypoglycemia.
In plain wordsIn older women with hip fracture, neither complex dose caused observed low blood sugar.
Peptide
IGF-1 (mecasermin)
Outcome
Not applicableHypoglycemia
Study
n = 20
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
Both doses were well tolerated, and no hypoglycemia or other therapy-induced side effects were observed.
3 context sentences(design, population, supporting numbers)
Summary · context
The aim of this randomized, double-blind, placebo- controlled pilot study was to evaluate the short-term safety and musculoskeletal effects of rhIGF-I/IGFBP-3 in older women (aged 65-90 yr) with recent hip fracture.
Summary · context
Within 72 h after the event, 30 patients received continuous administration of either placebo (n = 10), 0.5 mg/kg.d rhIGF-I/IGFBP-3 (n = 9), or 1 mg/kg.d rhIGF-I/IGFBP-3 (n = 11).
Summary · context
Treatment was administered by sc infusion through a portable mini-pump for a total of 8 wk after hip fracture surgery, with patient follow-up to 6 months after surgery.
In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).
Report a problemFND-1193228803
02HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialSafety outcome
In older women with hip fracture, neither complex dose produced other observed therapy-induced side effects.
In plain wordsIn older women with hip fracture, neither complex dose produced other observed treatment side effects.
Peptide
IGF-1 (mecasermin)
Outcome
Not applicableOther therapy-induced side effects
Study
n = 20
Outcome group
Adverse events · Whole body
Source sentences
Summary
Both doses were well tolerated, and no hypoglycemia or other therapy-induced side effects were observed.
3 context sentences(design, population, supporting numbers)
Summary · context
The aim of this randomized, double-blind, placebo- controlled pilot study was to evaluate the short-term safety and musculoskeletal effects of rhIGF-I/IGFBP-3 in older women (aged 65-90 yr) with recent hip fracture.
Summary · context
Within 72 h after the event, 30 patients received continuous administration of either placebo (n = 10), 0.5 mg/kg.d rhIGF-I/IGFBP-3 (n = 9), or 1 mg/kg.d rhIGF-I/IGFBP-3 (n = 11).
Summary · context
Treatment was administered by sc infusion through a portable mini-pump for a total of 8 wk after hip fracture surgery, with patient follow-up to 6 months after surgery.
In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).
Report a problemFND-1193228804
03HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome
In older women with hip fracture, the 1 mg/kg.d complex increased serum IGF-I from 83 to 393 ng/ml.
In plain wordsIn older women with hip fracture, the higher-dose complex raised serum IGF-I from baseline.
Peptide
IGF-1 (mecasermin)
Outcome
IncreaseIGF-I levels at higher dose
Study
n = 11
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Measurements
Serum IGF-I, mean
83 ng/ml
before treatment
Serum IGF-I, mean
393 ng/ml
1 mg/kg.d rhIGF-I/IGFBP-3
P value for mean serum IGF-I increase from baseline
< 0.001 P value
1 mg/kg.d rhIGF-I/IGFBP-3 versus baseline
Source sentences
Summary
During the administration of rhIGF-I/IGFBP-3, mean serum levels of IGF-I significantly (P < 0.001) increased from 83 ng/ml to 289 ng/ml (0.5 mg/kg.d) and 393 ng/ml (1 mg/kg.d), respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The aim of this randomized, double-blind, placebo- controlled pilot study was to evaluate the short-term safety and musculoskeletal effects of rhIGF-I/IGFBP-3 in older women (aged 65-90 yr) with recent hip fracture.
Summary · context
Within 72 h after the event, 30 patients received continuous administration of either placebo (n = 10), 0.5 mg/kg.d rhIGF-I/IGFBP-3 (n = 9), or 1 mg/kg.d rhIGF-I/IGFBP-3 (n = 11).
Summary · context
Treatment was administered by sc infusion through a portable mini-pump for a total of 8 wk after hip fracture surgery, with patient follow-up to 6 months after surgery.
In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).
Report a problemFND-1193228802
04HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome
In older women with hip fracture, hip bone density changed by -2.6% from baseline after higher-dose complex treatment, without statistical significance.
In plain wordsIn older women with hip fracture, hip bone density did not significantly change from baseline after higher-dose complex treatment.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeSix-month hip bone density
Study
n = 11
Outcome group
Bone and joint · Musculoskeletal
Measurements
Hip bone density change from baseline at 6 months postfracture
−2.6%
1 mg/kg.d rhIGF-I/IGFBP-3 group
P value for hip bone density change from baseline
0.53 P value
1 mg/kg.d rhIGF-I/IGFBP-3 versus baseline at 6 months postfracture
Source sentences
Summary
At 6 months postfracture (4 months after the 2-month infusion), they showed a statistically not significant decrease from baseline in hip bone density (-2.6%, P = 0.53).
3 context sentences(design, population, supporting numbers)
Summary · context
The aim of this randomized, double-blind, placebo- controlled pilot study was to evaluate the short-term safety and musculoskeletal effects of rhIGF-I/IGFBP-3 in older women (aged 65-90 yr) with recent hip fracture.
Summary · context
Within 72 h after the event, 30 patients received continuous administration of either placebo (n = 10), 0.5 mg/kg.d rhIGF-I/IGFBP-3 (n = 9), or 1 mg/kg.d rhIGF-I/IGFBP-3 (n = 11).
Summary · context
Treatment was administered by sc infusion through a portable mini-pump for a total of 8 wk after hip fracture surgery, with patient follow-up to 6 months after surgery.
In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).
Report a problemFND-1193228806
05HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome
In older women with hip fracture, grip strength increased 11.4% from baseline after the 1.0 mg/kg.d complex.
In plain wordsIn older women with hip fracture, grip strength increased from baseline after higher-dose complex treatment.
Peptide
IGF-1 (mecasermin)
Outcome
IncreaseGrip strength
Study
n = 11
Outcome group
Exercise and physical function · Musculoskeletal
Measurements
Grip strength change from baseline at end of study
11.4%
1.0 mg/kg.d rhIGF-I/IGFBP-3 group
Grip strength change from baseline at end of study
−11.6%
placebo group
P value for grip strength change from baseline
0.04 P value
1.0 mg/kg.d rhIGF-I/IGFBP-3 versus baseline at end of study
P value for grip strength change from baseline
0.16 P value
placebo versus baseline at end of study
Source sentences
Summary
Additionally, in patients treated with 1.0 mg/kg.d rhIGF-I/IGFBP-3, grip strength had increased from baseline by 11.4% by the end of the study (P = 0.04) whereas patients on placebo lost 11.6% from baseline (P = 0.16).
3 context sentences(design, population, supporting numbers)
Summary · context
The aim of this randomized, double-blind, placebo- controlled pilot study was to evaluate the short-term safety and musculoskeletal effects of rhIGF-I/IGFBP-3 in older women (aged 65-90 yr) with recent hip fracture.
Summary · context
Within 72 h after the event, 30 patients received continuous administration of either placebo (n = 10), 0.5 mg/kg.d rhIGF-I/IGFBP-3 (n = 9), or 1 mg/kg.d rhIGF-I/IGFBP-3 (n = 11).
Summary · context
Treatment was administered by sc infusion through a portable mini-pump for a total of 8 wk after hip fracture surgery, with patient follow-up to 6 months after surgery.
In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).
Report a problemFND-1193228807
06HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome
In older women with hip fracture, increased strength with the high-dose complex was associated with improved functional recovery.
In plain wordsIn older women with hip fracture, strength gains with the higher-dose complex were linked to improved functional recovery.
Peptide
IGF-1 (mecasermin)
Outcome
IncreaseFunctional recovery
Study
n = 11
Outcome group
Exercise and physical function · Musculoskeletal
Source sentences
Summary
This increase in muscle strength in the high-dose group was associated with a positive effect on functional recovery.
3 context sentences(design, population, supporting numbers)
Summary · context
The aim of this randomized, double-blind, placebo- controlled pilot study was to evaluate the short-term safety and musculoskeletal effects of rhIGF-I/IGFBP-3 in older women (aged 65-90 yr) with recent hip fracture.
Summary · context
Within 72 h after the event, 30 patients received continuous administration of either placebo (n = 10), 0.5 mg/kg.d rhIGF-I/IGFBP-3 (n = 9), or 1 mg/kg.d rhIGF-I/IGFBP-3 (n = 11).
Summary · context
Treatment was administered by sc infusion through a portable mini-pump for a total of 8 wk after hip fracture surgery, with patient follow-up to 6 months after surgery.
In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).
Report a problemFND-1193228808
07HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome
In older women with hip fracture, the 0.5 mg/kg.d complex increased serum IGF-I from 83 to 289 ng/ml.
In plain wordsIn older women with hip fracture, the lower-dose complex raised serum IGF-I from baseline.
Peptide
IGF-1 (mecasermin)
Outcome
IncreaseIGF-I levels at lower dose
Study
n = 9
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Measurements
Serum IGF-I, mean
83 ng/ml
before treatment
Serum IGF-I, mean
289 ng/ml
0.5 mg/kg.d rhIGF-I/IGFBP-3
P value for mean serum IGF-I increase from baseline
< 0.001 P value
0.5 mg/kg.d rhIGF-I/IGFBP-3 versus baseline
Source sentences
Summary
During the administration of rhIGF-I/IGFBP-3, mean serum levels of IGF-I significantly (P < 0.001) increased from 83 ng/ml to 289 ng/ml (0.5 mg/kg.d) and 393 ng/ml (1 mg/kg.d), respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The aim of this randomized, double-blind, placebo- controlled pilot study was to evaluate the short-term safety and musculoskeletal effects of rhIGF-I/IGFBP-3 in older women (aged 65-90 yr) with recent hip fracture.
Summary · context
Within 72 h after the event, 30 patients received continuous administration of either placebo (n = 10), 0.5 mg/kg.d rhIGF-I/IGFBP-3 (n = 9), or 1 mg/kg.d rhIGF-I/IGFBP-3 (n = 11).
Summary · context
Treatment was administered by sc infusion through a portable mini-pump for a total of 8 wk after hip fracture surgery, with patient follow-up to 6 months after surgery.
In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).
Report a problemFND-1193228801

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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Musculoskeletal effects of the recombinant human IGF-I/IGF binding protein-3 complex in osteoporotic patients with proximal femoral fracture: a double-blind, placebo-controlled pilot study.

Summary

Results from this study7

Studies that did not test the peptide alone7

Version history

Subjects

Publication types

MeSH terms