The Effect Of Oral Ibandronate In Male Osteoporosis - Study Results

The Effect Of Oral Ibandronate In Male Osteoporosis (STRONG)

This study has been completed.

Study NCT00397839 Information provided by Hoffmann-La Roche

First Received on November 9, 2006. Last Updated on November 17, 2009 History of Changes

Results First Received: November 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Male Osteoporosis
Interventions:	Drug: Ibandronate Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo orally at a dose of 150 mg once a month for 12 months
Ibandronate	Ibandronate orally at a dose of 150 mg once a month for 12 months

Participant Flow: Overall Study

	Placebo	Ibandronate
STARTED	48	87
COMPLETED	41	69
NOT COMPLETED	7	18

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo orally at a dose of 150 mg once a month for 12 months
Ibandronate	Ibandronate orally at a dose of 150 mg once a month for 12 months

Baseline Measures

	Placebo	Ibandronate	Total
Number of Participants [units: participants]	47	85	132
Age, Customized ^[1] [units: participants]
< 65 years	23	42	65
>= 65 years	24	43	67
Age ^[1] [units: years] Mean ± Standard Deviation	65.0 ± 10.63	63.9 ± 11.20	64.3 ± 10.98
Gender ^[1] [units: participants]
Female	0	0	0
Male	47	85	132

[1]	Safety analysis population

Outcome Measures

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1. Primary:

Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12 [ Time Frame: 12 months ]

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2. Secondary:

Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6 [ Time Frame: 6 months ]

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3. Secondary:

Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12 [ Time Frame: 12 months ]

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4. Secondary:

Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6 [ Time Frame: 6 months ]

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5. Secondary:

Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00397839 History of Changes
Other Study ID Numbers:	BON105960
Study First Received:	November 9, 2006
Results First Received:	November 17, 2009
Last Updated:	November 17, 2009
Health Authority:	United States: Food and Drug Administration