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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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

Baseline Measures

	Teriparatide	Alendronate	Total
Number of Participants [units: participants]	214	214	428
Age, Customized [units: participants]
Age < 35 years	13	19	32
35 <= Age < 50 years	55	35	90
50 <= Age < 65 years	86	93	179
Age >= 65 years	60	67	127
Gender [units: participants]
Female	172	173	345
Male	42	41	83
Region of Enrollment [units: participants]
United States	62	64	126
Belgium	8	8	16
Denmark	4	3	7
Austria	1	2	3
Norway	1	1	2
Argentina	23	20	43
Brazil	72	73	145
Colombia	10	9	19
Venezuela	4	3	7
Mexico	14	15	29
Finland	1	2	3
Germany	14	14	28
Origin [units: participants]
Caucasian	153	148	301
Non-Caucasian	61	66	127
Prior Bisphosphonate User [units: participants]
Yes	20	20	40
No	194	194	388
Baseline Biochemical Markers of Bone Metabolism [units: ug/L] Mean ± Standard Deviation
Serum N-terminal propeptide of type 1 procollagen	46.161 ± 35.471	47.235 ± 29.606	46.704 ± 32.562
Procollagen I carboxy-terminal propeptide	166.402 ± 99.625	152.109 ± 56.637	158.845 ± 79.910
Bone-specific alkaline phosphatase	9.465 ± 4.522	9.711 ± 4.527	9.595 ± 4.513
Osteocalcin	17.130 ± 14.422	15.878 ± 10.286	16.492 ± 12.468
Baseline Bone Mineral Density [units: grams per square centimeters] Mean ± Standard Deviation
Lumbar Spine Bone Mineral Density	0.845 ± 0.131	0.844 ± 0.128	0.845 ± 0.129
Total Hip Bone Mineral Density	0.744 ± 0.113	0.757 ± 0.124	0.750 ± 0.119
Femoral Neck Bone Mineral Density	0.682 ± 0.114	0.697 ± 0.119	0.689 ± 0.116
C-terminal telopeptide of type I collagen [units: pmol/L] Mean ± Standard Deviation	3790.483 ± 2478.189	4543.156 ± 4838.919	4185.328 ± 3907.204

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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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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

Other Adverse Events

	Teriparatide	Alendronate
Total, other (not including serious) adverse events
# participants affected	190	177
Blood and lymphatic system disorders
Anaemia ^†^A # participants affected / at risk # events	10/214 (4.67%) 10	16/214 (7.48%) 16
Gastrointestinal disorders
Abdominal pain ^†^A # participants affected / at risk # events	11/214 (5.14%) 12	10/214 (4.67%) 12
Abdominal pain upper ^†^A # participants affected / at risk # events	18/214 (8.41%) 19	16/214 (7.48%) 16
Dyspepsia ^†^A # participants affected / at risk # events	9/214 (4.21%) 9	15/214 (7.01%) 16
Gastritis ^†^A # participants affected / at risk # events	15/214 (7.01%) 15	8/214 (3.74%) 8
Nausea ^†^A # participants affected / at risk # events	36/214 (16.82%) 44	18/214 (8.41%) 23
Vomiting ^†^A # participants affected / at risk # events	13/214 (6.07%) 13	11/214 (5.14%) 12
Infections and infestations
Bronchitis ^†^A # participants affected / at risk # events	20/214 (9.35%) 32	17/214 (7.94%) 22
Influenza ^†^A # participants affected / at risk # events	18/214 (8.41%) 24	24/214 (11.21%) 29
Nasopharyngitis ^†^A # participants affected / at risk # events	7/214 (3.27%) 8	13/214 (6.07%) 21
Sinusitis ^†^A # participants affected / at risk # events	15/214 (7.01%) 23	18/214 (8.41%) 24
Urinary tract infection ^†^A # participants affected / at risk # events	20/214 (9.35%) 27	26/214 (12.15%) 31
Musculoskeletal and connective tissue disorders
Arthralgia ^†^A # participants affected / at risk # events	21/214 (9.81%) 26	19/214 (8.88%) 23
Back pain ^†^A # participants affected / at risk # events	24/214 (11.21%) 25	26/214 (12.15%) 28
Pain in extremity ^†^A # participants affected / at risk # events	10/214 (4.67%) 12	12/214 (5.61%) 15
Rheumatoid arthritis ^†^A # participants affected / at risk # events	15/214 (7.01%) 15	18/214 (8.41%) 18
Nervous system disorders
Dizziness ^†^A # participants affected / at risk # events	17/214 (7.94%) 20	15/214 (7.01%) 15
Headache ^†^A # participants affected / at risk # events	18/214 (8.41%) 23	14/214 (6.54%) 17
Psychiatric disorders
Depression ^†^A # participants affected / at risk # events	18/214 (8.41%) 19	16/214 (7.48%) 16
Insomnia ^†^A # participants affected / at risk # events	12/214 (5.61%) 12	3/214 (1.40%) 3
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^†^A # participants affected / at risk # events	13/214 (6.07%) 17	4/214 (1.87%) 6
Vascular disorders
Hypertension ^†^A # participants affected / at risk # events	21/214 (9.81%) 21	18/214 (8.41%) 18

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 10.0

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