Recruitment status was Active, not recruiting
TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in OLES and TRES combined.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An 18-Month, Open-Label Extension Study of Once-Daily ALX1-11 for the Treatment of Postmenopausal Women With Osteoporosis (TRES)|
- The primary objective of this study is to evaluate the safety of continued once-daily dosing with 100 mg ALX1-11 up to a maximum of 36 months in postmenopausal osteoporotic women who participated in TOP and OLES.
- The secondary objectives are to evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in BMD and other measures of bone quality and strength.
|Study Start Date:||January 2005|
The primary goal of osteoporosis therapy is to prevent fracture, and anabolic agents can accomplish this by strengthening bone structure, which is accompanied by changes in BMD. Effects of ALX1-11 on BMD have been previously documented in a dose-finding Phase II clinical trial in osteoporotic postmenopausal women taking calcium and vitamin D supplements, who were otherwise naive to osteoporosis therapies. The anabolic effects of ALX1-11 on lumbar vertebrae were statistically significant compared to placebo after 12 months of treatment. In addition, animal studies showed that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically (Mosekilde et al., 1991; Kimmel et al., 1993).
Protocol ALX1-11-93001 (TOP) assessed the effect of 18 months of ALX1-11 treatment on fracture incidence as a primary efficacy variable, and Protocol CL1-11-002 (OLES) assessed the effect on BMD for up to 24 months of treatment. Subjects who will be enrolled in the current study (TRES) will be those who received placebo in TOP and ALX1-11 in OLES. TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in the OLES and TRES combined.
|United States, California|
|'Osteoporosis Medical Center|
|Beverly Hills, California, United States, 90211|
|United States, Illinois|
|'The University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Michigan|
|'Michigan Bone & Mineral Clinic|
|Detroit, Michigan, United States, 48236|
|United States, North Dakota|
|'Odyssey Research Services|
|Bismarck, North Dakota, United States, 58501|
|Michael J. Lillestol|
|Fargo, North Dakota, United States, 58103|
|'Odyssey Research Services|
|Minot, North Dakota, United States, 58701|
|United States, South Dakota|
|'Rapid City Medical Center|
|Rapid City, South Dakota, United States, 57701|
|Watertown, South Dakota, United States, 57201|
|United States, Vermont|
|'Fletcher Allan Health Center, UHC Campus 1|
|Burlington, Vermont, United States, 05401|
|'Centro Médico T.I.E.M.P.O|
|Buenos Aires, BUE, Argentina, C1117ABH|
|Buenos Aires, BUE, Argentina, C1012AAR|
|'Centro de Osteopatias Medicas|
|Capital Federal, CBA, Argentina, C1114AAI|