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Danish Osteoporosis Prevention Study

This study has been completed.
Sponsor:
Collaborators:
Karen Elise Jensens Foundation
Novo Nordisk
LEO Pharma
Novartis
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00252408
First received: November 10, 2005
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
 Drug: Hormone replacement therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Danish Osteoporosis Prevention Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Fracture
  • Bone mineral density

Secondary Outcome Measures:
  • Breast cancer
  • Menopausal symptoms

Estimated Enrollment: 2000
Study Start Date: October 1990
Estimated Study Completion Date: December 2003
Detailed Description:

Aim: To study the ability of hormone replacement early after menopause on risk of fractures and changes in bone mineral density, and side effects.

The project was designed as a comprehensive cohort trial. One group accepted randomisation, and was randomised to hormone replacement therapy (HRT) or not (no placebo used).

502 were randomised to HRT, and 504 were randomised to no HRT) One group was allowed to choose HRT or not. A total of 221 chose HRT, and 789 chose no HRT.

First line HRT was oral sequential oestradiol/norethisterone in women with intact uterus and oral continuous oestradiol in hysterectomised women.

The study was initiated in 1990, and inclusion ended in 1993.

  Eligibility

Ages Eligible for Study:   45 Years to 58 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 45-58 years with an intact uterus
  • Three to 24 month past last menstrual bleeding
  • Hysterectomised women aged 45-52 years and having elevated FSH

Exclusion Criteria:

  • Metaboliv bone disease including osteoporosis defined as non-traumatic vertebral fractures on X-ray
  • Current estrogen use or estrogen use within the past three month
  • Current or past treatment with glucocorticoids for more than 6 month
  • Current or past malignancy
  • Newly diagnosed or uncontrolled chronic disease
  • Alcohol or drug addiction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252408

Locations
Denmark
The Osteoporosis Clinic, Aarhus Sygehus
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Karen Elise Jensens Foundation
Novo Nordisk
LEO Pharma
Novartis
Investigators
Study Chair: Leif Mosekilde, Professor MD DrMedSc department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
Study Director: Jens Erik Beck Jensen, MD PhD The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen
Study Director: Peder Charles, MD DrMedSc Department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
Study Director: Stig Pors Nielsen, MD DrMedSc Department of Clinical Physiology and Nuclear Medicine, Hillerød Hospital, Hillerød, Denmark
Study Director: Henning Beck Nielsen, MD DrMedSc Department of Endocrinology, Odense University Hospital, Odense, Denmark
Study Director: Kim Brixen, MD PhD Department of Endocrinology, Odense University Hospital, Odense, Denmark
Study Director: Ole Helmer Sørensen, MD DrMedSc The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00252408     History of Changes
Other Study ID Numbers: 1990/1821, DOPS
Study First Received: November 10, 2005
Last Updated: September 3, 2009
Health Authority: Denmark: Danish Medicines Agency
Denmark: National Board of Health

Keywords provided by University of Aarhus:
Fracture
Osteoporosis
Bone mineral density
 Hormone replacement therapy
Estrogen
Breast cancer

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013