Effect of simvastatin on bone markers in osteopenic women: a placebo-controlled, dose-ranging trial [ISRCTN85429598]
Background
Hydroxymethylglutaryl coenzyme A reductase inhibitors increase new bone formation in vitro and in rodents. Results of epidemiologic analyses evaluating the association between use of these cholesterol-lowering drugs, bone mineral density and fracture have been mixed.
Methods
Women (n = 24) with osteopenia, assessed by broad band ultrasound attenuation, were randomized to simvastatin 20 mg, 40 mg or identical-appearing placebo for 12 weeks. Fasting lipid profiles and biochemical markers of bone formation (bone-specific alkaline phosphatase) and resorption (N-telopeptides and C-terminal propeptide of type 1 collagen) were measured at baseline, 6 and 12 weeks.
Results
Plasma low density lipoprotein-cholesterol concentration fell 7%, 39% (p < 0.01 vs baseline) and 47% (p < 0.01 vs baseline) after 12 weeks of treatment with placebo, simvastatin 20 mg and 40 mg, respectively. At baseline, bone marker concentrations were similar in the three treatment groups. At 6 and 12 weeks, bone marker concentrations were not different from baseline, and no significant differences in bone marker concentrations were observed between treatment groups at either 6 or 12 weeks.
Conclusion
Among osteopenic women, treatment with simvastatin for 12 weeks did not affect markers of bone formation or resorption.
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Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| bureauCode |
[
"009:25"
]
|
| contactPoint |
{
"fn": "NIH",
"@type": "vcard:Contact",
"hasEmail": "mailto:info@nih.gov"
}
|
| description | Background Hydroxymethylglutaryl coenzyme A reductase inhibitors increase new bone formation in vitro and in rodents. Results of epidemiologic analyses evaluating the association between use of these cholesterol-lowering drugs, bone mineral density and fracture have been mixed. Methods Women (n = 24) with osteopenia, assessed by broad band ultrasound attenuation, were randomized to simvastatin 20 mg, 40 mg or identical-appearing placebo for 12 weeks. Fasting lipid profiles and biochemical markers of bone formation (bone-specific alkaline phosphatase) and resorption (N-telopeptides and C-terminal propeptide of type 1 collagen) were measured at baseline, 6 and 12 weeks. Results Plasma low density lipoprotein-cholesterol concentration fell 7%, 39% (p < 0.01 vs baseline) and 47% (p < 0.01 vs baseline) after 12 weeks of treatment with placebo, simvastatin 20 mg and 40 mg, respectively. At baseline, bone marker concentrations were similar in the three treatment groups. At 6 and 12 weeks, bone marker concentrations were not different from baseline, and no significant differences in bone marker concentrations were observed between treatment groups at either 6 or 12 weeks. Conclusion Among osteopenic women, treatment with simvastatin for 12 weeks did not affect markers of bone formation or resorption. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Official Government Data Source",
"mediaType": "text/html",
"description": "Visit the original government dataset for complete information, documentation, and data access.",
"downloadURL": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC79000/"
}
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|
| identifier | https://healthdata.gov/api/views/sich-8qw8 |
| issued | 2025-07-14 |
| keyword |
[
"bone-markers",
"clinical-trial",
"nih",
"osteopenia",
"simvastatin"
]
|
| landingPage | https://healthdata.gov/d/sich-8qw8 |
| modified | 2025-09-06 |
| programCode |
[
"009:032"
]
|
| publisher |
{
"name": "National Institutes of Health",
"@type": "org:Organization"
}
|
| theme |
[
"NIH"
]
|
| title | Effect of simvastatin on bone markers in osteopenic women: a placebo-controlled, dose-ranging trial [ISRCTN85429598] |
