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Status:

COMPLETED

Open Label Extension Study of PREOS

Lead Sponsor:

Shire

Conditions:

Osteoporosis

Eligibility:

FEMALE

45+ years

Phase:

PHASE3

Brief Summary

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 ...

Detailed Description

Effects of ALX1-11 on bone mineral density (BMD) have been documented in a dose-finding Phase II clinical trial in osteoporotic postmenopausal women, supplemented with calcium and Vitamin D3 but witho...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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
  • 1\. 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
  • SERM drugs, e.g., tamoxifen, raloxifene, Evista
  • Vaginal application of estrogen-containing creams unless the dose is:
  • conjugated estrogen or estradiol: maximum of 0.5 g twice each week (total of 1.0 g weekly)
  • Estrace (Ogen): maximum of 1.0 g twice each week (total of 2.0 g weekly)
  • Daily inhaled corticosteroid unless dose is equivalent to \<1200 µg/day of beclomethasone
  • Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., remicade \[infliximab\]
  • Methotrexate
  • The antimetabolite, methotrexate, which interferes with DNA synthesis, repair and cellular replication should not be used by patients participating in this OLES.
  • In general, immunomodulatory agents with antiproliferative activity are not permitted as a concomitant medication in this OLES.
  • Intra-articular injections
  • 1\. Patients may receive a maximum of one intra-articular injection (ONE JOINT ONLY) every 6 months while participating in this OLES. The joint that is injected may be a different joint every 6 months. The dose of corticosteroid injected should not exceed the anti-inflammatory equivalent dose of Prednisone 40 mg suspension. The dose and volume should be adjusted downward as appropriate to the size of the joint.
  • Provera is an acceptable concomitant medication when used according to the label instructions
  • Patients may be enrolled in this OLES if they have been stabilized on the following therapy for the specified amount of time:
  • Thyroid Hormone (\<0.1 mg/day thyroxine) therapy for at least 6 months If taking \> 0.1 mg/day but \< 0.2 mg/day, must have serum TSH level 1. \> 0.1mU/L. Patients will be excluded if they are taking doses of \> 0.2 mg/day.
  • 2\. However, if a patient has had a minimal change in L-thyroxine dose of \< 0.025 mg/day within 6 months of the baseline visit, and has been on this new dose for at least 2 months, the patient may be enrolled in this study. The patient's history with L-thyroxine must be clearly documented in the source documents.
  • 3\. If a patient requires an increase in their thyroid replacement dose, as recommended by a physician who is caring for the patient, after enrollment in this OLES, the patient must have a TSH and T4 level within 3 months of the dose change to ensure the patient does not become hyperthyroid
  • Stable dosage of thiazide for at least 3 consecutive months
  • C. Laboratory Values and Physical Examination Findings:
  • \- Serum calcium greater than 10.7 mg/dL (2.66 mmol/L) at baseline will be managed as outlined in Appendix 4
  • \- Urinary calcium to creatinine ratio greater than or equal to 1 at baseline will be managed as outlined in Appendix 5
  • Elevated total serum alkaline phosphates (\> 400 U/L) at baseline will be managed as outlined in Appendix 6 except as noted for Latin and South American countries.
  • Any other clinically significant abnormal value as judged by the investigator
  • D. Substance Abuse:
  • Alcohol and/or drug abuse
  • E. Compliance:
  • Suspected or confirmed poor compliance in completing clinical trial evaluations and/or clinical trial required questionnaires

Key Trial Info

Start Date :

October 16 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 13 2005

Estimated Enrollment :

1683 Patients enrolled

Trial Details

Trial ID

NCT00172133

Start Date

October 16 2001

End Date

April 13 2005

Last Update

May 17 2021

Active Locations (132)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 33 (132 locations)

1

'The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

'Rheumatology Associates of North Alabama

Huntsville, Alabama, United States, 35801

3

'Radiant Research - Phoenix North

Phoenix, Arizona, United States, 85013

4

'Osteoporosis Medical Center

Beverly Hills, California, United States, 90211