Trial Outcomes & Findings for A Study for Patients With Osteoporosis (NCT NCT00414973)
NCT ID: NCT00414973
Last Updated: 2009-10-28
Results Overview
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
364 participants
Primary outcome timeframe
Baseline to 24 weeks
Results posted on
2009-10-28
Participant Flow
364 participants were randomized, but 2 females did not receive study drug and are not included in any of the analyses.
Participant milestones
| Measure |
Teriparatide - Females
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
Intranasal, 200 International Units (IU)/day, 24 weeks
|
Teriparatide - Males
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Males
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
218
|
109
|
24
|
11
|
|
Overall Study
COMPLETED
|
190
|
99
|
21
|
11
|
|
Overall Study
NOT COMPLETED
|
28
|
10
|
3
|
0
|
Reasons for withdrawal
| Measure |
Teriparatide - Females
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
Intranasal, 200 International Units (IU)/day, 24 weeks
|
Teriparatide - Males
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Males
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
4
|
1
|
0
|
|
Overall Study
Adverse Event
|
10
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
3
|
4
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study for Patients With Osteoporosis
Baseline characteristics by cohort
| Measure |
Teriparatide - Females
n=218 Participants
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
n=109 Participants
Intranasal, 200 International Units (IU)/day, 24 weeks
|
Teriparatide - Males
n=24 Participants
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Males
n=11 Participants
Intranasal, 200 IU/day, 24 weeks
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
69.09 years
STANDARD_DEVIATION 6.95 • n=5 Participants
|
67.81 years
STANDARD_DEVIATION 7.22 • n=7 Participants
|
68.27 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
67.39 years
STANDARD_DEVIATION 11.01 • n=4 Participants
|
68.60 years
STANDARD_DEVIATION 7.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
327 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
218 participants
n=5 Participants
|
109 participants
n=7 Participants
|
24 participants
n=5 Participants
|
11 participants
n=4 Participants
|
362 participants
n=21 Participants
|
|
Race/Ethnicity
East Asian
|
218 participants
n=5 Participants
|
109 participants
n=7 Participants
|
24 participants
n=5 Participants
|
11 participants
n=4 Participants
|
362 participants
n=21 Participants
|
|
Duration of Osteoporosis
|
3.6 years
STANDARD_DEVIATION 5.33 • n=5 Participants
|
3.1 years
STANDARD_DEVIATION 4.16 • n=7 Participants
|
1.9 years
STANDARD_DEVIATION 2.24 • n=5 Participants
|
2.4 years
STANDARD_DEVIATION 2.54 • n=4 Participants
|
3.30 years
STANDARD_DEVIATION 4.80 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: Number of Intention to Treat patients with baseline and at least one post baseline measurement. Last Observation Carried Forward.
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Outcome measures
| Measure |
Teriparatide - Females
n=201 Participants
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
n=102 Participants
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|
|
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
|
6.04 percentage change in lumbar spine BMD
Standard Error 0.48
|
1.65 percentage change in lumbar spine BMD
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.
Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Outcome measures
| Measure |
Teriparatide - Females
n=205 Participants
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
n=104 Participants
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|
|
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women
|
-0.53 percentage change in total hip BMD
Standard Error 0.44
|
-0.62 percentage change in total hip BMD
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks and 24 weeksPopulation: Number of Intention to Treat patients with measurements at respective visits.
Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.
Outcome measures
| Measure |
Teriparatide - Females
n=218 Participants
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
n=109 Participants
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|
|
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women
Week 12 Percentage Change (n=202, n=102)
|
113.87 percentage change in osteocalcin
Inter-Quartile Range 21.46 • Interval 61.2 to 175.94
|
-7.67 percentage change in osteocalcin
Inter-Quartile Range 5.43 • Interval -20.51 to 12.56
|
|
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women
Week 24 Percentage Change (n=191, n=97)
|
137.45 percentage change in osteocalcin
Inter-Quartile Range 36.53 • Interval 74.34 to 261.68
|
-10.58 percentage change in osteocalcin
Inter-Quartile Range 8.21 • Interval -25.69 to 7.33
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Outcome measures
| Measure |
Teriparatide - Females
n=21 Participants
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
n=10 Participants
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|
|
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men
|
6.01 percentage change in lumbar spine BMD
Standard Error 1.20
|
3.38 percentage change in lumbar spine BMD
Standard Error 1.77
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.
Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Outcome measures
| Measure |
Teriparatide - Females
n=21 Participants
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
n=11 Participants
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|
|
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men
|
0.37 percentage change in total hip BMD
Standard Error 1.11
|
1.34 percentage change in total hip BMD
Standard Error 1.54
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks and 24 weeksPopulation: Number of Intention to Treat patients with measurements at respective visit.
Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.
Outcome measures
| Measure |
Teriparatide - Females
n=24 Participants
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
n=11 Participants
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|
|
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
Week 24 Percentage Change (n=21, n=11)
|
79.26 percentage change in osteocalcin
Inter-Quartile Range 26.94 • Interval 13.06 to 142.86
|
-17.65 percentage change in osteocalcin
Inter-Quartile Range 5.21 • Interval -27.95 to 3.08
|
|
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
Week 12 Percentage Change (n=21, n=11)
|
107.27 percentage change in osteocalcin
Inter-Quartile Range 14.88 • Interval 45.16 to 181.85
|
4.35 percentage change in osteocalcin
Inter-Quartile Range 13.48 • Interval -15.83 to 18.95
|
Adverse Events
Teriparatide - Females
Serious events: 8 serious events
Other events: 67 other events
Deaths: 0 deaths
Calcitonin - Females
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Teriparatide - Males
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Calcitonin - Males
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide - Females
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
Intranasal, 200 International Units (IU)/day, 24 weeks
|
Teriparatide - Males
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Males
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Cardiac disorders
Angina pectoris
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Cardiac disorders
Cardiac discomfort
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Cardiac disorders
Cardiac disorder
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Cardiac disorders
Heart valve incompetence
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
General disorders
Multi-organ failure
|
0.00%
0/217
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Pneumonia
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Infections and infestations
Sinusitis fungal
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/217
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/217
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/217
|
0.91%
1/110 • Number of events 1
|
0.00%
0/24
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/217
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
Other adverse events
| Measure |
Teriparatide - Females
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Females
Intranasal, 200 International Units (IU)/day, 24 weeks
|
Teriparatide - Males
Subcutaneous, 20 micrograms/day, 24 weeks
|
Calcitonin - Males
Intranasal, 200 IU/day, 24 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
2.8%
6/217 • Number of events 8
|
0.91%
1/110 • Number of events 1
|
0.00%
0/24
|
0.00%
0/11
|
|
Gastrointestinal disorders
Diarrhoea
|
0.92%
2/217 • Number of events 2
|
1.8%
2/110 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Nausea
|
5.1%
11/217 • Number of events 15
|
0.00%
0/110
|
0.00%
0/24
|
0.00%
0/11
|
|
General disorders
Asthenia
|
1.4%
3/217 • Number of events 3
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Thirst
|
0.46%
1/217 • Number of events 1
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
7/217 • Number of events 7
|
3.6%
4/110 • Number of events 5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/217
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/217
|
0.91%
1/110 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/217
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Blood alkaline phosphatase increased
|
4.6%
10/217 • Number of events 10
|
0.91%
1/110 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Blood creatine phosphokinase increased
|
0.92%
2/217 • Number of events 2
|
0.91%
1/110 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Blood uric acid increased
|
4.6%
10/217 • Number of events 10
|
0.00%
0/110
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.46%
1/217 • Number of events 1
|
0.91%
1/110 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
6/217 • Number of events 8
|
0.91%
1/110 • Number of events 3
|
0.00%
0/24
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.5%
12/217 • Number of events 19
|
3.6%
4/110 • Number of events 8
|
0.00%
0/24
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.6%
10/217 • Number of events 19
|
1.8%
2/110 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Dizziness
|
7.4%
16/217 • Number of events 23
|
3.6%
4/110 • Number of events 5
|
8.3%
2/24 • Number of events 2
|
0.00%
0/11
|
|
Nervous system disorders
Headache
|
2.3%
5/217 • Number of events 7
|
3.6%
4/110 • Number of events 6
|
0.00%
0/24
|
0.00%
0/11
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60