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| Sponsored by: |
Kuopio University Hospital |
|---|---|
| Information provided by: | Kuopio University Hospital |
| ClinicalTrials.gov Identifier: | NCT00877097 |
Purpose
Recent studies suggest that the combination of two inhibitors of bone resorption may induce a greater increase in bone mineral density (BMD) than either agent alone.
In this 5-year partly randomized study the investigators examined the effects of hormone therapy (HT) with or without bisphosphonate on BMD on osteoporotic women.
In the Kuopio Osteoporosis Study (OSTPRE) a population based sample of 3200 women were selected for BMD measurement by Lunar DPX in 1995-1997. In all 167 women aged 61±2.7 years (11±4.9 years postmenopausal), and the T-score < -2.5 SD at either the lumbar spine or femoral neck were recruited for this sub-study.
They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac, which consisted of either 800mg clodronate (Bonefos®, Leiras Ltd, Finland) (n=55, KB-group) or placebo (n=55, K-group). In case of contraindications or refusal from HT, the women were offered clodronate 800 mg/day (n=57, B-group) to be taken to empty stomach with a glass of water 30 minutes to two hours before breakfast.
BMD was measured at time intervals 0, 1, 3 and 5-years. All repeated BMD values were interviewed by one investigator and primarily the vertebrae L2-L4 were followed. In case of spinal deformities during the study (38.3%) other lumbar levels were followed. The baseline BMD values (lumbar spine BMD 0.839±0.072 g/cm², femoral neck BMD 0.759±0.094g/cm²) were similar between the groups.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Drug: Klodronate and Kliogest Procedure: Placebo+ Kliogest Drug: Bonefos |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Clinical Trial on the Effectts of Estradiol 2 mg + NETA 1 mg With or Without Clodronate on Bone Mineral Density and Bone Markers of Osteoporotic Postmenopausal 167 Finnish Women. |
| Enrollment: | 167 |
| Study Start Date: | July 1996 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Clodronate 800 mg / day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.
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Drug: Klodronate and Kliogest |
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2: Placebo Comparator
Placebo 2 tablets/ day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.
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Procedure: Placebo+ Kliogest |
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3: Active Comparator
Clodronate 800 mg / day for five years.
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Drug: Bonefos |
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Kuopio University Hospital ( Mari Ollikainen ) |
| Study ID Numbers: | KUH5302410, Compliance 1x/year x5, BP 1x/year 5 yrs, endometrial sample 1x/yearx5, adverse effects 1x/year x5 |
| Study First Received: | April 2, 2009 |
| Last Updated: | April 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00877097 History of Changes |
| Health Authority: | Finland: National Agency for Medicines |
|
osteoporosis Bone mineral density clodronate HRT postmenopausal |
|
Clodronic Acid Musculoskeletal Diseases Estradiol 3-benzoate Estradiol valerate Osteoporosis Bone Density Conservation Agents |
Bone Diseases, Metabolic Estradiol 17 beta-cypionate Polyestradiol phosphate Hormones Bone Diseases Estradiol |
|
Clodronic Acid Musculoskeletal Diseases Physiological Effects of Drugs Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |
