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Danish Osteoporosis Prevention Study

NCT00252408 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2009-09-04

No results posted yet for this study

Summary

Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in early postmenopausal women.

The project was initiated in 1990, and the inclusion ended in 1993. A total of 2,016 early postmenopausal women were divided into two groups: The first group accepted randomisation to HRT or not, and the second group was allowed to choose HRT or not.

The study was not blinded. Main measurements were fracture risk over 20 years, changes in bone mineral density over 20 years, and side effects, mainly breast cancer.

Conditions

Interventions

DRUG

Hormone replacement therapy

Sponsors & Collaborators

  • Karen Elise Jensen Foundation

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • LEO Pharma

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Leif Mosekilde, Professor MD DrMedSc · department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark

  • Jens Erik Beck Jensen, MD PhD · The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen

  • Peder Charles, MD DrMedSc · Department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark

  • Stig Pors Nielsen, MD DrMedSc · Department of Clinical Physiology and Nuclear Medicine, Hillerød Hospital, Hillerød, Denmark

  • Henning Beck Nielsen, MD DrMedSc · Odense University Hospital

  • Kim Brixen, MD PhD · Odense University Hospital

  • Ole Helmer Sørensen, MD DrMedSc · The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
58 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1990-10-31
Completion
2003-12-31

Countries

  • Denmark

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00252408 on ClinicalTrials.gov