Open Label Extension Study of PREOS

Completed · Phase 3

Conditions studied: Osteoporosis

In brief

This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.

Key facts

Study ID: NCT00172133
Run by: Shire
People needed: 1683
Starts: 2001-10-16
Expected to finish: 2005-04-13
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…

Women who completed 18 months of treatment in Protocol ALX1-11-93001; or
Women prematurely discontinued from Protocol ALX1-11-93001 who want to participate in OLES for the events listed below must have their clinical course reviewed and approved by the CAB for enrollment into the OLES:
Clinical or incident lumbar vertebral fractures as assessed by the central imaging organization
Clinical or incident hip fracture
Confirmed bone loss at A/P lumbar vertebra or total hip or femoral neck as assessed by the central imaging organization
Body weight below 40 kg
Development of an exclusion criterion in Protocol ALX1-11-93001
It must be accepted by patients whose clinical courses are reviewed by the CAB that participation in OLES may require additional tests at baseline and/or during the study to ensure their utmost safety.
Women with the ability to self-administer a daily injection or have a designee who will give the injections;
Women who are capable of understanding and giving written, voluntary informed consent before the start of open-label dosing with ALX1-11.

You may not qualify if…

A. History or Concurrent Illness:
Disorders of Immunity Endocrine system Gastrointestinal system Kidney and collecting system Liver, biliary tract and pancreatic systems Musculoskeletal system
Patients with chronic, active joint disease requiring more than one intra-articular injection every 6 months Neoplasia
Patients who have had squamous or basal cell carcinoma of the skin may enter this study if:
The lesion(s) were fully resected with clear margins described in a written report by a pathologist, and
The patient has had no recurrence of lesions for at least one year from the time of the original resection.
Nervous system Vascular, respiratory and cardiac system *Significant diseases or disorders are determined by history, physical exam or laboratory tests and judged by the Principal Investigator to be significant.
B. Concurrent Medication:
Patients may not use any of the following therapies while they are enrolled in this OLES without permission from the Sponsor and the PMO:
Tetracycline antibiotics for four weeks prior to bone biopsy
Any PTH analogs [e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs]
Fluoride
Strontium
Phenytoin for seizure control
Any investigational drug other than ALX1-11
Anabolic steroids or androgens
Active Vitamin D3 metabolites and analogs, e.g., calcitriol
Systemic corticosteroids, more than 5 mg/day prednisone or a systemic corticosteroid formulation equivalent to 5 mg/day prednisone
A patient who has been enrolled into the OLES and needs to receive an acute bolus of steroids (oral or injectable) for a self-limited illness may continue treatment in the study if the following requirements are met:
Exposure to steroids will be limited to no more than 30 consecutive days
The maximal dose of steroid (prednisone equivalent) must be limited to no more than 225 mg (7.5 mg each day for 30 days)
The illness is acute in nature and is not expected to recur during the remaining period of the study
Bisphosphonates, including investigational bisphosphonates
Calcitonin
Estrogen replacement therapy by oral, transdermal or intramuscular administration

Where it is running

'Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
'Radiant Research - Phoenix North — Phoenix, Arizona, United States
'Osteoporosis Medical Center — Beverly Hills, California, United States
'East Bay Clinical Trial Center — Concord, California, United States
'Loma Linda Osteoporosis Research Center — Loma Linda, California, United States
Foundation for Osteoporosis Research — Oakland, California, United States
'Desert Medical Advances — Palm Desert, California, United States
'VA Palo Alto Health Care System — Palo Alto, California, United States
'Boling Clinical Trials — Rancho Cucamonga, California, United States
'S.D. Arthritis & Osteoporosis Medical Clinic — San Diego, California, United States
'Radiant Research - San Diego — San Diego, California, United States
'San Francisco General Hospital — San Francisco, California, United States
'Longmont Medical Research Network — Longmont, Colorado, United States
'Northeast Clinical Research, LLC — Hamden, Connecticut, United States
'RASF - Clinical Research Center — Boca Raton, Florida, United States
'The Center for Diabetes and Endocrine Care — Hollywood, Florida, United States
'Florida Wellcare Alliance — Inverness, Florida, United States
'Renstar Medical Group — Ocala, Florida, United States
'The Arthritis Center — Palm Harbor, Florida, United States
'The Centre for Arthritis and Rheumatic Diseases — South Miami, Florida, United States
'Radiant Research - Stuart & LakeWorth — Stuart, Florida, United States
'Palm Beach Research Center — West Palm Beach, Florida, United States
'Radiant Research — Honolulu, Hawaii, United States
'Intermountain Orthopaedics — Boise, Idaho, United States
'The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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