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

NCT ID: NCT00877097

Last Updated: 2009-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-07-31
• Study Completion Date: 2009-02-28

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Klodronate and Kliogest

Intervention Type: DRUG

2

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

Group Type: PLACEBO_COMPARATOR

Placebo+ Kliogest

Intervention Type: PROCEDURE

3

Clodronate 800 mg / day for five years.

Group Type: ACTIVE_COMPARATOR

Bonefos

Intervention Type: DRUG

Interventions

Klodronate and Kliogest

Intervention Type: DRUG

Placebo+ Kliogest

Intervention Type: PROCEDURE

Bonefos

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Postmenopausal
• BMD T-score <-2.5sd

Exclusion Criteria

• None

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kuopio University Hospital

Principal Investigators

Marjo T Tuppurainen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Obstetrics and Gynecology, Kuopio University Hospital

References

Tuppurainen M, Harma K, Komulainen M, Kiviniemi V, Kroger H, Honkanen R, Alhava E, Jurvelin J, Saarikoski S. Effects of continuous combined hormone replacement therapy and clodronate on bone mineral density in osteoporotic postmenopausal women: a 5-year follow-up. Maturitas. 2010 Aug;66(4):423-30. doi: 10.1016/j.maturitas.2010.04.013. Epub 2010 May 23.

Reference Type: DERIVED

PMID: 20547017 (View on PubMed)

Other Identifiers

Compliance 1x/year x5

Identifier Type: -

Identifier Source: secondary_id

BP 1x/year 5 yrs

Identifier Type: -

Identifier Source: secondary_id

endometrial sample 1x/yearx5

Identifier Type: -

Identifier Source: secondary_id

adverse effects 1x/year x5

Identifier Type: -

Identifier Source: secondary_id

KUH5302410

Identifier Type: -

Identifier Source: org_study_id