Post-Menopausal OsteoporosisPhase 4NCT00503113

A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

A Phase 4 study testing ibandronate [Bonviva/Boniva] and Alendronate in people with Post-Menopausal Osteoporosis, run by Hoffmann-La Roche at 44 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older, women only
Conditions the study is for: Post-Menopausal Osteoporosis
What is being tested?: ibandronate [Bonviva/Boniva] and Alendronate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 801 participants
Where: 44 sitesin 6 countries
Study dates: Jul 2007to Apr 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

female patients, >=60 years of age;
>=5 years postmenopausal;
confirmed osteoporosis, at increased risk for renal disease.

Who cannot join

inability to stand or sit upright for 30 minutes;
hypersensitivity to bisphosphonates;
malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
previous administration of an i.v. bisphosphonate;
oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;
history of major upper gastrointestinal disease.

Trial locations and contacts

44 sites in 6 countries.

Country

City, postcode or hospital

44 sites in 6 countries

United States15 sites

Study site
Albuquerque, New Mexico, 87106
Study site
Bethesda, Maryland, 20817
Study site
Birmingham, Alabama, 35294
Study site
Bismarck, North Dakota, 58501
Study site
Cincinnati, Ohio, 45224
Study site
Duncansville, Pennsylvania, 16635
Study site
Fargo, North Dakota, 58103
Study site
Gainesville, Georgia, 30501
Study site
Lakewood, Colorado, 80227
Study site
Morehead City, North Carolina, 28557
Study site
Norfolk, Virginia, 23502
Study site
Omaha, Nebraska, 68131
Study site
Riverside, California, 92505
Study site
Topeka, Kansas, 66604
Study site
West Palm Beach, Florida, 33401

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Argentina9 sites

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Buenos Aires, C1012-CFed
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Buenos Aires, C1117ABH
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Buenos Aires, C1128AAF
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Buenos Aires, C1405BCH
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Buenos Aires, C1425 AWC
Study site
Buenos Aires, C1425AGC
Study site
Córdoba, X5000BNB
Study site
Santa Fe, 2000

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Brazil7 sites

Study site
Brasília, 71625-009
Study site
Curitiba, 80030-110
Study site
Goiânia, 74110-120
Study site
Porto Alegre, 90610-000
Study site
Rio de Janeiro, 22271-100
Study site
São Paulo, 04266-010
Study site
Vitória, 29055-450

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Mexico5 sites

Study site
Guadalajara, 44629
Study site
Mexico City, 11000
Study site
Monterrey, 64460
Study site
Obregón, 85000
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San Jerónimo Chicahualco, 52170

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South Africa5 sites

Study site
Durban, 3630
Study site
Johannesburg, 2196
Study site
Parow, 7500
Study site
Port Elizabeth, 6001
Study site
Somerset West, 7130

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Switzerland3 sites

Study site
Basel, 4055
Study site
Bern, 3010
Study site
Zurich, 8091

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About this study

Official title: A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Conditions: Post-Menopausal Osteoporosis
Being tested: ibandronate [Bonviva/Boniva], Alendronate
Medical subject headings: Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ibandronate [Bonviva/Boniva]Drug
3mg intravenous (iv) injection every 3 months
ibandronate [Bonviva/Boniva]Drug
3mg intravenous (iv) infusion every 3 months
AlendronateDrug
70mg per oral (po) weekly

Study groups in NCT00503113
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: ibandronate [Bonviva/Boniva]
2	Experimental	Not described Receives: Drug: ibandronate [Bonviva/Boniva]
3	Active comparator	Not described Receives: Drug: Alendronate

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
Measured: Baseline and 9 months

Secondary outcomes (7)

Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.
Measured: Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Measured: Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using CG Formula)
Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Measured: Baseline and 9 months
Absolute Change From Baseline in Mean Serum Creatinine.
Measured: Baseline and 9 months
Relative Change From Baseline in Mean Serum Creatinine.
Measured: Baseline and 9 months
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Measured: Baseline and 9 months
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.
Measured: Baseline and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Apr 2010

First posted18 Jul 2007 (estimated)
Study startJul 2007
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Post-Menopausal OsteoporosisStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 801 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00503113
Sponsor's protocol ID: BA20341
Status last verified: May 2011
First submitted: 17 Jul 2007
Last updated: 17 Jun 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.
PubMed 34231877

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
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Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis
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EFFECT OF CIRCUIT TRAINING ON BONE MINERAL DENSITY IN POST MENOPAUSAL PERIOD
Post Menopausal, Osteoporosis

All Post-Menopausal Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
ClinicalTrials.gov ID: NCT00503113
Acronym / sponsor ID: BA20341
Conditions: Post-Menopausal Osteoporosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 801 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 18 Jul 2007 (estimated)
Results: Posted 17 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: ibandronate [Bonviva/Boniva]
2	Experimental	Drug: ibandronate [Bonviva/Boniva]
3	Active comparator	Drug: Alendronate

Who may qualify

Ages: 60 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

female patients, >=60 years of age;
>=5 years postmenopausal;
confirmed osteoporosis, at increased risk for renal disease.

Key exclusion criteria (6 listed)

inability to stand or sit upright for 30 minutes;
hypersensitivity to bisphosphonates;
malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
previous administration of an i.v. bisphosphonate;
oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;

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
ibandronate [Bonviva/Boniva]3mg intravenous (iv) injection every 3 months	Drug	1
ibandronate [Bonviva/Boniva]3mg intravenous (iv) infusion every 3 months	Drug	2
Alendronate70mg per oral (po) weekly	Drug	3

Primary outcome

Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
Time frame: Baseline and 9 months
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.

7 secondary outcomes

Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
Time frame: Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
Time frame: Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using CG Formula)
Time frame: Baseline and 9 months
Absolute Change From Baseline in Mean Serum Creatinine.
Time frame: Baseline and 9 months
Relative Change From Baseline in Mean Serum Creatinine.
Time frame: Baseline and 9 months
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Time frame: Baseline and 9 months
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Time frame: Baseline and 9 months

Results and safety

Results posted to the registry on 17 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ibandronate 3 mg Injection	268	235
Ibandronate 3 mg Infusion	264	236
Alendronate 70 mg Oral	269	241

Primary outcome: Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)

Time frame: Baseline and 9 months. Mean (Standard Deviation). Unit: mL/min

Measure	Ibandronate 3 mg Injection n = 246	Ibandronate 3 mg Infusion n = 243	Alendronate 70 mg Oral n = 241
Baseline	72.5 (18.25)	71.5 (18.07)	70.5 (16.67)
Change from baseline at 9 months (n=233,232,225)	-1.3 (7.14)	-0.5 (7.86)	-1.6 (5.89)

Population analysed: Per Protocol (PP) Population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.. Other adverse events reported at 2.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ibandronate 3 mg Injection	19 of 263 (7.2%)	196 of 263 (74.5%)	Not reported
Ibandronate 3 mg Infusion	15 of 263 (5.7%)	190 of 263 (72.2%)	Not reported
Alendronate 70 mg Oral	13 of 267 (4.9%)	191 of 267 (71.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34231877Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.

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.

Clinical Trials study director

Hoffmann-La Roche

44 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ibandronate [Bonviva/Boniva] and Alendronate in people with Post-Menopausal Osteoporosis, run by Hoffmann-La Roche at 44 sites in 6 countries.

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 3 inclusion and 6 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 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Argentina, Brazil, Mexico, South Africa and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) (time frame: Baseline and 9 months). 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 NCT00503113, 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 17 Jun 2011.

A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (3 listed)

Key exclusion criteria (6 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)

Adverse events

Research links

Related trials for Post-Menopausal Osteoporosis

Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis

Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD

Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture

Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis

EFFECT OF CIRCUIT TRAINING ON BONE MINERAL DENSITY IN POST MENOPAUSAL PERIOD

Referral and contact

Questions about this trial

Log in to keep searching

Participant flow

Primary outcome: Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)

Adverse events