OsteoporosisPhase 4NCT00252408
Danish Osteoporosis Prevention Study
A Phase 4 study testing Hormone replacement therapy in people with Osteoporosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 45 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Hormone replacement therapy
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 1990to Dec 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Hormone replacement therapy
- Keywords
- Fracture, Osteoporosis, Bone mineral density, Hormone replacement therapy, Estrogen, Breast cancer
- Medical subject headings
- Osteoporosis, Fractures, Bone, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone replacement therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
Bone mineral density
Secondary outcomes (2)
Breast cancer
Menopausal symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startOct 1990
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Karen Elise Jensen Foundation, Novo Nordisk A/S, LEO Pharma, Novartis
- Investigators
- Leif Mosekilde, Professor MD DrMedSc, Study chair, department of Endocrinology and Metabolism C, Aarhus University Hospital, DenmarkJens Erik Beck Jensen, MD PhD, Study director, The Osteoporosis Clinic, Hvidovre Hospital, CopenhagenPeder Charles, MD DrMedSc, Study director, Department of Endocrinology and Metabolism C, Aarhus University Hospital, DenmarkStig Pors Nielsen, MD DrMedSc, Study director, Department of Clinical Physiology and Nuclear Medicine, Hillerød Hospital, Hillerød, DenmarkHenning Beck Nielsen, MD DrMedSc, Study director, Odense University HospitalKim Brixen, MD PhD, Study director, Odense University HospitalOle Helmer Sørensen, MD DrMedSc, Study director, The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252408
- Sponsor's protocol ID
- 1990/1821
- Other IDs
- DOPS
- Status last verified
- Sep 2009
- First submitted
- 10 Nov 2005
- Last updated
- 4 Sep 2009
- Results posted
- No
Publications
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.
PubMed 11063900Torekov 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.
PubMed 24446656Schierbeck 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.
PubMed 23048011
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Osteoporosis Prevention Study
- ClinicalTrials.gov ID
- NCT00252408
- Acronym / sponsor ID
- 1990/1821
- Conditions
- Osteoporosis
- Keywords
- Fracture, Osteoporosis, Bone mineral density, Hormone replacement therapy, Estrogen, Breast cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Karen Elise Jensen Foundation, Novo Nordisk A/S, LEO Pharma, Novartis
- Study start
- Oct 1990
- Study completion
- Dec 2003
- First posted
- 11 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormone replacement therapy | Drug | – |
Primary outcome
Fracture
Bone mineral density
2 secondary outcomes
Breast cancer
Menopausal symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2009.
- Results publication: PubMed 11063900Mosekilde 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.
- Derived from this study: PubMed 24446656Torekov 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.
- Derived from this study: PubMed 23048011Schierbeck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif Mosekilde, Professor MD DrMedSc study chair
department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
Jens Erik Beck Jensen, MD PhD study director
The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen
Peder Charles, MD DrMedSc study director
Department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hormone replacement therapy in people with Osteoporosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00252408, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2009.