Danish Osteoporosis Prevention Study

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

Study Description

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 Design

• 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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Fracture
2. Bone mineral density

Secondary Outcome Measures :

1. Breast cancer
2. Menopausal symptoms

Eligibility Criteria

• 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

Contacts and Locations

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; Odense University Hospital
• Study Director: Kim Brixen, MD PhD; Odense University Hospital
• Study Director: Ole Helmer Sørensen, MD DrMedSc; The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark

More Information

Publications of Results:

Mosekilde L, Beck-Nielsen H, Sorensen 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 fracture incidence in recent postmenopausal women - results of the Danish Osteoporosis Prevention Study. Maturitas. 2000 Oct 31;36(3):181-93. doi: 10.1016/s0378-5122(00)00158-4.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Torekov SS, Harslof T, Rejnmark L, Eiken P, Jensen JB, Herman AP, Hansen T, Pedersen O, Holst JJ, Langdahl BL. A functional amino acid substitution in the glucose-dependent insulinotropic polypeptide receptor (GIPR) gene is associated with lower bone mineral density and increased fracture risk. J Clin Endocrinol Metab. 2014 Apr;99(4):E729-33. doi: 10.1210/jc.2013-3766. Epub 2014 Jan 21.

Schierbeck LL, Rejnmark L, Tofteng CL, Stilgren L, Eiken P, Mosekilde L, Kober L, Jensen JE. Effect of hormone replacement therapy on cardiovascular events in recently postmenopausal women: randomised trial. BMJ. 2012 Oct 9;345:e6409. doi: 10.1136/bmj.e6409.

• ClinicalTrials.gov Identifier: NCT00252408
• Other Study ID Numbers: 1990/1821; DOPS
• First Posted: November 11, 2005
• 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