NCT00252408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 1990

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1990

Completed
13.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

First QC Date

November 10, 2005

Last Update Submit

September 3, 2009

Conditions

Osteoporosis

Keywords

FractureOsteoporosisBone mineral densityHormone replacement therapyEstrogenBreast cancer

Outcome Measures

Primary Outcomes (2)

  • Fracture

  • Bone mineral density

Secondary Outcomes (2)

  • Breast cancer

  • Menopausal symptoms

Interventions

Hormone replacement therapyDRUG

Eligibility Criteria

Age45 Years - 58 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Osteoporosis Clinic, Aarhus Sygehus

Aarhus, DK-8000, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 11063900RESULT

  • 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.

    PMID: 24446656DERIVED

  • 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.

    PMID: 23048011DERIVED

MeSH Terms

Conditions

OsteoporosisFractures, BoneBreast Neoplasms

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Leif Mosekilde, Professor MD DrMedSc

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

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 11, 2005

Study Start

October 1, 1990

Study Completion

December 1, 2003

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

DK(1)