Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Condition:	Osteoporosis
Interventions:	Drug: Teriparatide Drug: Alendronate Sodium Drug: Placebo

Participant Flow

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
Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Participant Flow: Overall Study

	Teriparatide	Alendronate
STARTED	214	214
COMPLETED	123	118
NOT COMPLETED	91	96
Adverse Event	30	18
Withdrawal by Subject	29	42
Death	9	15
Lost to Follow-up	4	13
Protocol Violation	3	4
Protocol Entry Criteria Unmet	1	2
Sponsor Decision	6	1
Unspecified	2	1
Significant Lab Value	2	0
Physician Decision	5	0

Baseline Characteristics

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Outcome Measures

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1. Primary:

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ 18 month endpoint ]

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2. Secondary:

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ 18 month endpoint ]

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3. Secondary:

Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined [ 3, 6, 12, 18, 24, 36 months ]

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4. Secondary:

Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ 3, 6, 12, and 18 months ]

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5. Secondary:

Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined [ 24 and 36 months and Endpoint at 36 months ]

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6. Secondary:

Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined [ 18, 24, 36 months, and 18 and 36 month endpoints ]

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7. Secondary:

Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined [ 18, 24, 36 months, and 18 and 36 month endpoints ]

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8. Secondary:

Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined [ 12, 18, 24, and 36 months ]

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9. Secondary:

Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined [ 12, 18, 24, and 36 months ]

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10. Secondary:

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen [ 1, 6, 18, and 36 months ]

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11. Secondary:

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen [ 1, 6, 18, and 36 months ]

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12. Secondary:

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase [ 1, 6, 18, and 36 months ]

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13. Secondary:

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments [ 1, 6, 18, and 36 months ]

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14. Secondary:

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin [ 1, 6, 18, and 36 months ]

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15. Secondary:

Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures [ 36 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 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI 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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979

No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Saag KG, Shane E, Boonen S, Marín F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39.

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	6484, B3D-US-GHBZ
Study First Received:	January 13, 2003
Results First Received:	January 14, 2009
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00051558 History of Changes
Health Authority:	United States: Food and Drug Administration