OsteoporosisOsteoNCT00877097
Effects of Continuous Combined Hormone Replacement Therapy and Clodronate on Bone Mineral Density (BMD) in Osteoporotic Women
A study testing Klodronate and Kliogest and Bonefos in people with Osteoporosis, run by Kuopio University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Klodronate and Kliogest and Bonefos
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- Jul 1996to Feb 2009
- Phase
- Interventional
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal
- BMD T-score <-2.5sd
Who cannot join
- None
About this 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.
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.
Read more
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
- Being tested
- Klodronate and Kliogest, Placebo+ Kliogest, Bonefos
- Keywords
- osteoporosis, Bone mineral density, clodronate, HRT, postmenopausal
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Klodronate and KliogestDrug
Placebo+ KliogestProcedure or surgery
BonefosDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clodronate 800 mg / day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years. Receives: Drug: Klodronate and Kliogest |
| 2 | Placebo comparator | Placebo 2 tablets/ day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years. Receives: Procedure: Placebo+ Kliogest |
| 3 | Active comparator | Clodronate 800 mg / day for five years. Receives: Drug: Bonefos |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD once a year
Measured: 1996-2002
Secondary outcomes (1)
bone markers once a year
Measured: 1996-2002
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJul 1996
- Primary completionDec 2002
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marjo T Tuppurainen, MD, PhD, Principal investigator, Dept. of Obstetrics and Gynecology, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877097
- Sponsor's protocol ID
- KUH5302410
- Other IDs
- Compliance 1x/year x5, BP 1x/year 5 yrs, endometrial sample 1x/yearx5, adverse effects 1x/year x5
- Acronym
- Osteo
- Status last verified
- Apr 2009
- First submitted
- 2 Apr 2009
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20547017
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00877097
- Acronym / sponsor ID
- Osteo / KUH5302410
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, Bone mineral density, clodronate, HRT, postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jul 1996
- Primary completion
- Dec 2002 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 7 Apr 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Klodronate and KliogestClodronate 800 mg / day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years. |
| 2 | Placebo comparator | Procedure: Placebo+ KliogestPlacebo 2 tablets/ day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years. |
| 3 | Active comparator | Drug: BonefosClodronate 800 mg / day for five years. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal
- BMD T-score <-2.5sd
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Klodronate and Kliogest | Drug | 1 |
| Placebo+ Kliogest | Procedure or surgery | 2 |
| Bonefos | Drug | 3 |
Primary outcome
BMD once a year
Time frame: 1996-2002
1 secondary outcome
bone markers once a year
Time frame: 1996-2002
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 7 Apr 2009.
- Derived from this study: PubMed 20547017Tuppurainen 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.
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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.
Marjo T Tuppurainen, MD, PhD principal investigator
Dept. of Obstetrics and Gynecology, Kuopio University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Klodronate and Kliogest and Bonefos in people with Osteoporosis, run by Kuopio University Hospital.
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 2 inclusion and 1 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 7 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
BMD once a year (time frame: 1996-2002). 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 NCT00877097, which also lists 1 linked publication.
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 7 Apr 2009; AzTrials last refreshed its copy on 6 Nov 2026.