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Sponsored by: |
NPS Pharmaceuticals |
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Information provided by: | NPS Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00172172 |
This study is evaluating the effects of calcium supplementation on the efficacy and safety of recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis. The primary objective of this clinical study is to evaluate whether increases in bone mineral density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: ALX1-11 |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study to Evaluate the Effects of Calcium Supplementation on the Efficacy and Safety of Recombinant Human Parathyroid Hormone (ALX1-11) in Postmenopausal Women With Osteoporosis (CAP Study) |
Estimated Enrollment: | 375 |
Study Start Date: | February 2004 |
Study Completion Date: | April 2005 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Effects of ALX1-11 on bone mineral density (BMD) have been documented in a dose-finding Phase II clinical trial in osteoporotic postmenopausal women, supplemented with calcium and Vitamin D3 but without any other treatment for osteoporosis. The anabolic effects of ALX1-11 in the lumbar vertebrae were statistically significant after the 12-month treatment period and more pronounced than any approved therapy. Additionally, animal studies have shown that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically.
The primary objective of this clinical study is to evaluate whether increases in bone mineral density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation.
A secondary objective of this clinical study are to evaluate whether changes in other efficacy parameters, such as bone mineral content (BMC) and biochemical markers of bone turnover, for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases observed for subjects treated with ALX1-11 and receiving calcium supplementation.
This is a double-blind, multi-centered, randomized, placebo-controlled, parallel-group study comprised of 3 treatment groups: ALX1-11 injection plus oral calcium, ALX1-11 injection plus oral placebo calcium, and placebo ALX1-11 injection plus oral calcium. All subjects also receive 400 IU oral vitamin D3. The dose of ALX1-11 to be used in this study is 100 μg, self administered by daily sc injection. The calcium dose is 700 mg/day.
Additional supplemental calcium and/or Vitamin D3 will not be permitted. Patients will be monitored for the development of hypercalcemia and/or hypercalciuria.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women 45-54 years of age with the following T-score and/or vertebral fracture
Women >=55 years of age with the following T-score and/or vertebral fracture:
The following types of vertebral fractures should not be considered for subject enrollment into this study:
Exclusion Criteria:
A. Vertebral Deformity (assessed as described in Appendix 2 of the protocol, are sufficient for exclusion):
Vertebral deformities
B. DXA Imaging:
Inability to have a DXA scan performed, e.g.:
C. History of or Concurrent Illness:
Disorders of Immunity
Endocrine system
Gastrointestinal system
Kidney and collecting system
Liver, biliary tract and pancreatic systems
Musculoskeletal system
Neoplasia
(**)Patients who have had either squamous or basal cell carcinoma of the skin can enroll if:
The patient has had no recurrence of lesions for at least one year from the time of the original resection.
Nervous system
Vascular, respiratory and cardiac system
(*) Significance will be determined by the investigator on the basis of history, physical exam, and/or laboratory screens. Significant disorders necessitate ongoing changes in therapeutic medication or frequent monitoring.
D. Concurrent Medication:
Patients cannot be enrolled into this clinical trial if they have received any of the following therapies at any time:
Patients must have been off the following agents for the specified times before entering the screening phase of this clinical trial:
Systemic corticosteroids, more than 5mg/day formulation equivalent to 5mg/day prednisone (>12 consecutive month or as acute bolus for nonrecurring condition). A patient who has been enrolled in the study and needs to receive an acute bolus of steroids (oral or injectable) for a self-limited illness may continue treatment in the study if the following requirements are met:
Bisphosphonates, including investigational bisphosphonates
If the patient has received bisphosphonates for more than 12 months at any time.
Has taken bisphosphonates for >=30 days but <=90 days, and has completed washout of equivalent time.
No washout is necessary if the patient has taken bisphosphonates <30 days.
Intravenous (IV) pamidronate
Cyclical Etidronate
Phenytoin for seizure control:
If the patient has received phenytoin <5 years before, the patient is excluded from this study
>=15 years have passed since the last dose of phenytoin or if use was between 5-15 years before the screening visit and the patient received phenytoin for <2 months
Patients may be enrolled if they have been stabilized on the following therapy for the specified amount of time:
Thyroid Hormone (<0.1 mg/day thyroxine) therapy for >=6 months
If taking >= 0.1 mg/day but <= 0.2 mg/day, must have serum TSH level >= 0.1 mU/L. Patients will be excluded if they are taking doses of >0.2 mg/day.
All patients must stop the following therapies at least 4 weeks before starting the stabilization period and will remain off these therapies for the remainder of the clinical study. The informed consent must be signed prior to the washout of any therapy. Screening laboratories must be performed only after the washout is complete. However, imaging studies (BMD, X-rays) may be performed prior to starting the calcitonin, estrogen, or Selective Estrogen Receptor Modulation (SERM) washout.
E. Miscellaneous Concurrent Medications
Intra-articular injections
F. Laboratory Values and Physical Examination Findings:
For laboratory values, the levels shown below are the upper limits for exclusions based on specific test results. For weight, the limit is the lower limit.
G. Substance Abuse:
H. Compliance:
Subjects are excluded if they exhibit suspected or confirmed poor compliance in completing clinical study evaluations and/or clinical study required questionnaires.
Responsible Party: | NPS Pharmaceuticals ( Director of Clinical Operations ) |
Study ID Numbers: | CL1-11-008 |
Study First Received: | September 13, 2005 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00172172 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Post-menopausal Osteoporosis Parathyroid Hormone PTH ALX1-11 |
Calcium, Dietary Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic |
Hormones Bone Diseases Menopause |
Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |