Danish Osteoporosis Prevention Study

Osteoporosis Clinical Trial

Official title:

Danish Osteoporosis Prevention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252408
• Other study ID #: 1990/1821
• Secondary ID: DOPS
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2005
• Last updated: September 3, 2009
• Start date: October 1990
• Est. completion date: December 2003

Study information

• Verified date: September 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 58 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Hormone replacement therapy

Locations

Country	Name	City	State
Denmark	The Osteoporosis Clinic, Aarhus Sygehus	Aarhus

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Karen Elise Jensen Foundation, LEO Pharma, Novartis, Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Mosekilde L, Beck-Nielsen H, Sørensen OH, Nielsen SP, Charles P, Vestergaard P, Hermann AP, Gram J, Hansen TB, Abrahamsen B, Ebbesen EN, Stilgren L, Jensen LB, Brot C, Hansen B, Tofteng CL, Eiken P, Kolthoff N. Hormonal replacement therapy reduces forearm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture
Primary	Bone mineral density
Secondary	Breast cancer
Secondary	Menopausal symptoms