Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Subjects are excluded who have developed any of the exclusion criteria for OLES, or modifications as listed below.
Concurrent Diseases Subjects are excluded if they have developed any of the diseases or illnesses listed since enrollment in OLES.
(*)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.
(**)Subjects who have had either squamous or basal cell carcinoma of the skin can enroll if: 1. The lesion(s) was fully resected with clear margins described in a written report by a pathologist, AND 2. The subject has had no recurrence of lesions for at least 1 year from the time of the original resection
Prohibited Concomitant Medications
(*)PTH (parathyroid hormone) analogs include PTH(1-34), PTHrP, and other analogs
(**)eg, azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., infliximab [Remicade™])
Medications Requiring a Washout Period - Subjects who completed OLES and then began taking medications listed in the following table may enroll in this study after a washout period of 30 days.
(*)Includes estrogen- and estrogen/progesterone-replacement therapy given by oral, transdermal, or intramuscular administration b SERMs (selective estrogen receptor modulator) include tamoxifen and raloxifene (Evista®) PMO = project medical officer
(**)SERMs (selective estrogen receptor modulator) include tamoxifen and raloxifene (Evista®) PMO = project medical officer
Medications Allowed if Specific Conditions Are Met-Medications that are allowed under specific conditions are listed:
Laboratory Values and Physical Examination Findings - For excluded laboratory values, the levels shown in the following table are the upper limits for exclusions based on specific test results, with the exception of calculated creatinine clearance and serum 25(OH) vitamin D, for which the limits are lower. All exclusionary laboratory results should be confirmed by a repeat test. Subjects may be excluded for any other clinically abnormal value, as determined by the investigator.
(*)Exclude subject only if repeat assessment confirms the result.
(**)Not to be used as a reason for premature discontinuation during the study. Subjects with elevated values after enrollment are to be managed by the appropriate algorithm (Appendices 2 and 3).
(***)Not an exclusion criterion in OLES
Substance Abuse-Subjects are excluded for a history of alcohol and/or drug abuse as determined by the investigator.
Compliance-Subjects may be excluded for suspected or confirmed poor compliance in completing clinical trial evaluations and/or questionnaires.
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal