Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone
Summary
The purpose of this study is to determine the maximum tolerated concentration (MTC) of bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20 to bisphosphonate alone.
Study Design
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Conditions
Risk Factors for or a Diagnosis of Osteoporosis
Intervention
rHuPH20
Location
Healthcare Discoveries, LLC/ICON Development Solutions
San Antonio
Texas
United States
78209
Status
Active, not recruiting
Source
Halozyme Therapeutics
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00807963
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Osteoporosis
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.
Causality
The relating of causes to the effects they produce. Causes are termed necessary when they must always precede an effect and sufficient when they initiate or produce an effect. Any of several factors may be associated with the potential disease causation or outcome, including predisposing factors, enabling factors, precipitating factors, reinforcing factors, and risk factors.
Risk Sharing, Financial
Any system which allows payors to share some of the financial risk associated with a particular patient population with providers. Providers agree to adhere to fixed fee schedules in exchange for an increase in their payor base and a chance to benefit from cost containment measures. Common risk-sharing methods are prospective payment schedules (PROSPECTIVE PAYMENT SYSTEM), capitation (CAPITATION FEES), diagnosis-related fees (DIAGNOSIS-RELATED GROUPS), and pre-negotiated fees.
Confounding Factors (epidemiology)
Factors that can cause or prevent the outcome of interest, are not intermediate variables, and are not associated with the factor(s) under investigation. They give rise to situations in which the effects of two processes are not separated, or the contribution of causal factors cannot be separated, or the measure of the effect of exposure or risk is distorted because of its association with other factors influencing the outcome of the study.
Alendronate
A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.
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