Open Label Extension
TRES
An 18-month, Open-label Extension Study of Once-daily ALX1-11 for the Treatment of Postmenopausal Women With Osteoporosis (TRES)
1 other identifier
interventional
91
2 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2005
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2006
CompletedMay 17, 2021
May 1, 2021
1.8 years
September 12, 2005
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to evaluate the safety of continued once-daily dosing with 100 mg ALX1-11 in postmenopausal osteoporotic women who participated in TOP and OLES clinical trials.
Throughout the study period of approximately 18 months.
Secondary Outcomes (1)
The secondary objective is to evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in bone mineral density (BMD).
Throughout the study period of approximately 18 months.
Interventions
Eligibility Criteria
You may qualify if:
- Received placebo in TOP
- Completed 18 months of daily treatment with ALX1-11 in OLES
- Received their last dose of ALX1-11 in OLES within 3 months (90 days) of dosing in this study
- Have the ability to continue to self-administer, or have a designee administer, a daily injection
- Have the ability to understand, and willingness to sign, an informed consent form (ICF)
You may not qualify if:
- Concurrent Diseases Subjects are excluded if they have developed any of the diseases or illnesses listed since enrollment in OLES.
- Immune.Significant\* immunological disorders; including AIDSAllergies to ALX1-11 or its constituents
- Endocrine.Significant\* endocrine disorders, including hyper or hypoparathyroidism, Cushing's disease, hyperthyroidism
- Gastrointestinal (GI).Significant\* GI disorders
- Kidney and Collecting.Significant\* renal disorders or impaired renal function, nephrolithiasis or urolithiasis, verified kidney calcification, etc.
- Liver, biliary tract, pancreatic.Significant\* hepatic or pancreatic disorders, active hepatitis, or pancreatitis
- Musculoskeletal.Metabolic bone disease, eg., Paget's disease, osteogenesis imperfecta, or osteomalacia -Chronic, active joint disease and/or joint infection
- Neoplasia.Cancer, with the exception of squamous or basal cell carcinoma\*\*
- Nervous.Significant\* neurological or psychiatric disease
- Vascular, respiratory, and cardiac.Significant\* unstable cardiac or pulmonary disease
- (\*)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 analogs\*
- Fluoride
- +38 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (12)
'Osteoporosis Medical Center
Beverly Hills, California, 90211, United States
'The University of Chicago
Chicago, Illinois, 60637, United States
'Michigan Bone & Mineral Clinic
Detroit, Michigan, 48236, United States
'Odyssey Research Services
Bismarck, North Dakota, 58501, United States
Michael J. Lillestol
Fargo, North Dakota, 58103, United States
'Odyssey Research Services
Minot, North Dakota, 58701, United States
'Rapid City Medical Center
Rapid City, South Dakota, 57701, United States
'Brown Clinic
Watertown, South Dakota, 57201, United States
'Fletcher Allan Health Center, UHC Campus 1
Burlington, Vermont, 05401, United States
'IDIM
Buenos Aires, BUE, C1012AAR, Argentina
'Centro Médico T.I.E.M.P.O
Buenos Aires, BUE, C1117ABH, Argentina
'Centro de Osteopatias Medicas
Capital Federal, CBA, C1114AAI, Argentina
Related Publications (1)
Zanchetta JR, Bogado CE, Cisari C, Aslanidis S, Greisen H, Fox J, Lems W. Treatment of postmenopausal women with osteoporosis with PTH(1-84) for 36 months: treatment extension study. Curr Med Res Opin. 2010 Nov;26(11):2627-33. doi: 10.1185/03007995.2010.524121. Epub 2010 Oct 5.
PMID: 20923256DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
January 10, 2005
Primary Completion
October 27, 2006
Study Completion
October 27, 2006
Last Updated
May 17, 2021
Record last verified: 2021-05