Know Cancer

forgot password

Danish Osteoporosis Prevention Study

Phase 4
45 Years
58 Years
Not Enrolling

Thank you

Trial Information

Danish Osteoporosis Prevention 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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:


Principal Investigator

Leif Mosekilde, Professor MD DrMedSc

Investigator Role:

Study Chair

Investigator Affiliation:

department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark


Denmark: Danish Medicines Agency

Study ID:




Start Date:

October 1990

Completion Date:

December 2003

Related Keywords:

  • Osteoporosis
  • Fracture
  • Osteoporosis
  • Bone mineral density
  • Hormone replacement therapy
  • Estrogen
  • Breast cancer
  • Osteoporosis