Effects of Continuous Combined Hormone Replacement Therapy and Clodronate on Bone Mineral Density (BMD) in Osteoporotic Women

Sponsor

Kuopio University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00877097

Collaborator

(none)

167

Enrollment

Arms

151.1

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Klodronate and Kliogest Procedure: Placebo+ Kliogest Drug: Bonefos	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

Jul 1, 1996

Actual Primary Completion Date :

Dec 1, 2002

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Clodronate 800 mg / day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.	Drug: Klodronate and Kliogest
Placebo Comparator: 2 Placebo 2 tablets/ day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.	Procedure: Placebo+ Kliogest
Active Comparator: 3 Clodronate 800 mg / day for five years.	Drug: Bonefos

Arm

Intervention/Treatment

Experimental: 1

Clodronate 800 mg / day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.

Drug: Klodronate and Kliogest

Placebo Comparator: 2

Placebo 2 tablets/ day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.

Procedure: Placebo+ Kliogest

Active Comparator: 3

Clodronate 800 mg / day for five years.

Drug: Bonefos

Outcome Measures

Primary Outcome Measures

BMD once a year [1996-2002]

Secondary Outcome Measures

bone markers once a year [1996-2002]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Postmenopausal
BMD T-score <-2.5sd

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kuopio University Hospital

Investigators

Principal Investigator: Marjo T Tuppurainen, MD, PhD, Dept. of Obstetrics and Gynecology, Kuopio University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00877097

Other Study ID Numbers:

KUH5302410
Compliance 1x/year x5
BP 1x/year 5 yrs
endometrial sample 1x/yearx5
adverse effects 1x/year x5

First Posted:

Apr 7, 2009

Last Update Posted:

Apr 7, 2009

Last Verified:

Apr 1, 2009

Keywords provided by , ,

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2009