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

Tracking Information

First Received Date ^ICMJE

November 10, 2005

Last Updated Date

September 3, 2009

Start Date ^ICMJE

October 1990

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Fracture
Bone mineral density

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00252408 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Breast cancer
Menopausal symptoms

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Danish Osteoporosis Prevention Study

Official Title ^ICMJE

Danish Osteoporosis Prevention Study

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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: Hormone replacement therapy

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2000

Completion Date

December 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

45 Years to 58 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00252408

Other Study ID Numbers ^ICMJE

1990/1821, DOPS

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Karen Elise Jensens Foundation
Novo Nordisk
LEO Pharma
Novartis

Investigators ^ICMJE

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

Information Provided By

University of Aarhus

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top