Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172107
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2005-09-12
Brief Title:
A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 50 75 and 100µg in the Treatment of Postmenopausal Osteoporosis
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Double Blind Placebo Controlled Parallel-Group Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 50 75 and 100µg in the Treatment of Postmenopausal Osteoporosis
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double-blind placebo-controlled parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 recombinant human parathyroid hormone rhPTH1-8450 75 and 100 µg in the treatment of postmenopausal osteoporosis The primary objective of this study is to compare the efficacy of ALX1-11 50 75 and 100 µg with that of placebo in terms of increasing vertebral bone mineral density when given daily by subcutaneous injection for 12 months in postmenopausal women with osteoporosis
Detailed Description:
Human clinical experience with a synthetic human parathyroid hormone fragment rhPTH 1-34 and animal studies with ALX1-11 demonstrate consistent increases in bone mineral density Furthermore the newly formed bone is normal in structure and composition Therefore ALX1-11 recombinant human parathyroid hormone rhPTH 1-84 has the potential to stimulate new bone formation in osteoporotic patients thereby increasing trabecular bone density and preventing fractures The clinical profile for ALX1-11 can be expected to be unique since none of the approved therapies for osteoporosis are able to form the quantities of new bone that ALX1-11 is potentially capable of Patients with bone density below the fracture threshold osteopenia as well as those with established vertebral fractures osteoporosis would be expected to benefit from treatment
Animal toxicology studies have been completed and there were no results to indicate any restrictions in the clinical usage of the drug Preliminary human clinical experience with ALX1-11 in healthy postmenopausal females has demonstrated no apparent risk of frank hypercalcemia at single administrations up to 50 µgkg or daily administrations for 7 days up to 20 µgkgday
Based on these studies the anticipated therapeutic range of ALX1-11 is 50-100 µg per day approx 10 - 15 µgkgday Therefore the dose range to be tested in this study will include an anticipated minimally effective dose interim dose and maximally tolerable dose 50 75 and 100 µg The efficacy of 3 doses of ALX1-11 will be assessed in terms of bone mineral density and biochemical markers of bone turnover in postmenopausal women
The primary objective of this study is to determine the dose-response relationship of ALX1-11 in terms of bone mineral density The efficacy of the 3 doses of ALX1-11 relative to placebo will be determined by measurement of bone mineral density by DXA at baseline and at 3 6 and 12 months
Patients will administer a daily subcutaneous injection of 05 mL of either 50 75 or 100 µg of ALX1-11 or placebo every morning for 12 months
Women will be advised to use the provided calcium supplements 500mg elemental calcium to maintain a total daily intake of 1000-1500 mgday and vitamin D supplements will also be provided 400 IUday A dietary questionnaire will be done at visit screen 6 and 15
If a patients total serum calcium measurement during the treatment phase demonstrates frank hypercalcemia OR if her pre-dose calcium levels are more than 05 mgdL or 0125 mmolL above the upper limit of normal 278 mmolL or 111 mgdL then the patients serum calcium level must be repeated
If upon re-test a patient continues to demonstrate frank hypercalcemia OR if her basal pre-dose calcium levels continues to be elevated above the upper limit of normal then the patient will be withdrawn from the study
Frank Hypercalcemia defined as total serum calcium levels above 111 mgdL or 278 mmolL
Animal toxicology studies have been completed and there were no results to indicate any restrictions in the clinical usage of the drug Preliminary human clinical experience with ALX1-11 in healthy postmenopausal females has demonstrated no apparent risk of frank hypercalcemia at single administrations up to 50 µgkg or daily administrations for 7 days up to 20 µgkgday
Based on these studies the anticipated therapeutic range of ALX1-11 is 50-100 µg per day approx 10 - 15 µgkgday Therefore the dose range to be tested in this study will include an anticipated minimally effective dose interim dose and maximally tolerable dose 50 75 and 100 µg The efficacy of 3 doses of ALX1-11 will be assessed in terms of bone mineral density and biochemical markers of bone turnover in postmenopausal women
The primary objective of this study is to determine the dose-response relationship of ALX1-11 in terms of bone mineral density The efficacy of the 3 doses of ALX1-11 relative to placebo will be determined by measurement of bone mineral density by DXA at baseline and at 3 6 and 12 months
Patients will administer a daily subcutaneous injection of 05 mL of either 50 75 or 100 µg of ALX1-11 or placebo every morning for 12 months
Women will be advised to use the provided calcium supplements 500mg elemental calcium to maintain a total daily intake of 1000-1500 mgday and vitamin D supplements will also be provided 400 IUday A dietary questionnaire will be done at visit screen 6 and 15
If a patients total serum calcium measurement during the treatment phase demonstrates frank hypercalcemia OR if her pre-dose calcium levels are more than 05 mgdL or 0125 mmolL above the upper limit of normal 278 mmolL or 111 mgdL then the patients serum calcium level must be repeated
If upon re-test a patient continues to demonstrate frank hypercalcemia OR if her basal pre-dose calcium levels continues to be elevated above the upper limit of normal then the patient will be withdrawn from the study
Frank Hypercalcemia defined as total serum calcium levels above 111 mgdL or 278 mmolL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None