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

Primary Purpose

Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Klodronate and Kliogest

Placebo+ Kliogest

Bonefos

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, Bone mineral density, clodronate, HRT, postmenopausal

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Postmenopausal
BMD T-score <-2.5sd

Exclusion Criteria:

None

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm Description

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

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

Clodronate 800 mg / day for five years.

Outcomes

Primary Outcome Measures

BMD once a year

Secondary Outcome Measures

bone markers once a year

Full Information

NCT ID

NCT00877097

First Posted

April 2, 2009

Last Updated

April 6, 2009

Sponsor

Kuopio University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00877097

Brief Title

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

Acronym

Osteo

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 Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

July 1996 (undefined)

Primary Completion Date

December 2002 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kuopio University Hospital

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

osteoporosis, Bone mineral density, clodronate, HRT, postmenopausal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

Clodronate 800 mg / day for five years.

Intervention Type

Drug

Intervention Name(s)

Klodronate and Kliogest

Intervention Type

Procedure

Intervention Name(s)

Placebo+ Kliogest

Intervention Type

Drug

Intervention Name(s)

Bonefos

Primary Outcome Measure Information:

Title

BMD once a year

Time Frame

1996-2002

Secondary Outcome Measure Information:

Title

bone markers once a year

Time Frame

1996-2002

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Postmenopausal BMD T-score <-2.5sd Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marjo T Tuppurainen, MD, PhD

Organizational Affiliation

Dept. of Obstetrics and Gynecology, Kuopio University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

20547017

Citation

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.

Results Reference

derived

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

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