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Effect of simvastatin on bone markers in osteopenic women: a placebo-controlled, dose-ranging trial [ISRCTN85429598]

Metadata Updated: September 7, 2025

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.

Access & Use Information

Public: This dataset is intended for public access and use. License: No license information was provided. If this work was prepared by an officer or employee of the United States government as part of that person's official duties it is considered a U.S. Government Work.

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Dates

Metadata Created Date July 24, 2025
Metadata Updated Date September 7, 2025

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date July 24, 2025
Metadata Updated Date September 7, 2025
Publisher National Institutes of Health
Maintainer
NIH
Identifier https://healthdata.gov/api/views/sich-8qw8
Data First Published 2025-07-14
Data Last Modified 2025-09-06
Category NIH
Public Access Level public
Bureau Code 009:25
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Harvest Object Id 879e44c8-b1ce-437a-87ae-be77047ef4c3
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL https://healthdata.gov/d/sich-8qw8
Program Code 009:032
Source Datajson Identifier True
Source Hash eb82a8ab04a88e55eb2d11bbb132fba3bd2395cded895bce1580398cec43d950
Source Schema Version 1.1

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