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Trial record 74 of 74 for:    estrogen replacement therapy

Danish Osteoporosis Prevention Study

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ClinicalTrials.gov Identifier: NCT00252408
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : September 4, 2009
Sponsor:
Collaborators:
Karen Elise Jensen Foundation
Novo Nordisk A/S
LEO Pharma
Novartis
Information provided by:
University of Aarhus

Brief 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.


Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Hormone replacement therapy Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Danish Osteoporosis Prevention Study
Study Start Date : October 1990
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Fracture
  2. Bone mineral density

Secondary Outcome Measures :
  1. Breast cancer
  2. Menopausal symptoms


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Ages Eligible for Study:   45 Years to 58 Years   (Adult)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252408


Locations
Denmark
The Osteoporosis Clinic, Aarhus Sygehus
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Karen Elise Jensen Foundation
Novo Nordisk A/S
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

Publications of Results:
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
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: September 4, 2009
Last Verified: September 2009

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
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs