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Completed

NCT Number: NCT00252408

Danish Osteoporosis Prevention Study

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Breast Diseases Breast Neoplasms Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

45 year–58 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Osteoporosis Clinic, Aarhus Sygehus

Aarhus, DK-8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hormone replacement therapy

Drug

Primary outcomes

  1. Fracture

  2. Bone mineral density

Secondary outcomes

  1. Breast cancer

  2. Menopausal symptoms

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Karen Elise Jensen Foundation
  • LEO Pharma
  • Novartis
  • Novo Nordisk A/S

Registry information

Important dates

Study start
1990
Study completion
2003
First posted
Nov 11, 2005
Registry last updated
Sep 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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