Open Label Extension

Completed · Phase 3

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00172120

Run by

Shire

People needed

91

Starts

2005-01-10

Expected to finish

2006-10-27

Last updated by the study team

2021-05-17

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

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…

• 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.
• 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
• Strontium
• Calcitonin
• Vitamin D metabolites or analogs(eg., calcitriol)
• Immunomodulatory agents with antiproliferative activity
• Cytostatics**
• Thyroxine. Prohibited if dose > 0.2 mg/day (see Table 4-4 for allowed conditions)
• Bisphosphonate
• Anabolic steroids or androgens
• (*)PTH (parathyroid hormone) analogs include PTH(1-34), PTHrP, and other analogs

Where it is running

• 'Osteoporosis Medical Center — Beverly Hills, California, United States
• 'The University of Chicago — Chicago, Illinois, United States
• 'Michigan Bone & Mineral Clinic — Detroit, Michigan, United States
• 'Odyssey Research Services — Bismarck, North Dakota, United States
• Michael J. Lillestol — Fargo, North Dakota, United States
• 'Odyssey Research Services — Minot, North Dakota, United States
• 'Rapid City Medical Center — Rapid City, South Dakota, United States
• 'Brown Clinic — Watertown, South Dakota, United States
• 'Fletcher Allan Health Center, UHC Campus 1 — Burlington, Vermont, United States
• 'IDIM — Buenos Aires, BUE, Argentina
• 'Centro Médico T.I.E.M.P.O — Buenos Aires, BUE, Argentina
• 'Centro de Osteopatias Medicas — Capital Federal, CBA, Argentina

Full record on ClinicalTrials.gov

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