TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoporosis

In brief

This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH \[1-84\]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.

Key facts

Study ID

NCT00172081

Run by

Shire

People needed

2532

Starts

2000-04-27

Expected to finish

2003-11-07

Last updated by the study team

2021-05-14

Who can join

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

You may qualify if…

• Women who are postmenopausal with at least one year since the last menstruation.
• Women who are 45-54 years of age with the following bone mineral density (BMD) and/or vertebral fracture:
• BMD 3.0 standard deviations (SDs) or more below peak bone mass of young females at the lumbar spine, femoral neck, or total hip; or
• BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip with the presence of a vertebral fracture verified by the central imaging organization before the patient is enrolled into the study.
• Women 55 or more years of age with the following BMD and/or vertebral fracture:
• BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip; or
• BMD 2.0 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip with the presence of a vertebral fracture verified by the central imaging organization before the patient is enrolled into the study.
• The following types of vertebral fractures should not be considered for patient enrollment into this trial:
• Pathological fractures due to malignant disease or infection
• Fractures due to excessive trauma sufficient to cause a fracture in young individuals with normal bone mass
• 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 clinical trial screening visit

You may not qualify if…

• A. Vertebral Deformity:
• Patient has 5 or more vertebral (thoracic and lumbar) deformities
• Patient has 2 or more lumbar vertebral deformities (L1 to L4)
• Severe lumbar scoliosis (>15 degrees) which precludes a reliable evaluation of the dual x-ray absorptiometry (DXA)
• B. DXA Imaging:
• Inability to have a DXA scan performed.
• C. History or Concurrent Illness:
• Disorders of immunity
• Endocrine system
• Gastrointestinal system
• Kidney and collecting system
• Liver, biliary tract and pancreatic systems
• Musculoskeletal system
• Neoplasia
• Nervous system
• Vascular, respiratory and cardiac system
• Significant diseases or disorders are determined by history, physical exam or laboratory screens and judged by the Principal Investigator to be significant.
• D. Concurrent Medication:
• Any patient who does not require medication washout (discontinuation) as specified below may start study drug dosing after 2 weeks of stabilization treatment with calcium and vitamin D3 supplements. All exceptions will be documented in the case report form (CRF).
• Patients cannot be enrolled into this clinical trial if they have received any of the following therapies at any time:
• Any PTH or PTH analogs [e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs]
• Fluoride
• Strontium
• Patients must have been off the following agents for the specified times before entering the screening phase of this clinical trial:
• Any investigational drug (30 days)

Where it is running

• 'The University of Alabama at Birmingham — Birmingham, Alabama, United States
• 'Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• 'Radiant Research - Phoenix — Phoenix, Arizona, United States
• 'Robin K. Dore, M.D., Inc. — Anaheim, California, 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
• 'The Foundation for Osteoporosis Research and Education — 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
• 'Radiant Research - San Diego — San Diego, California, United States
• 'S.D. Arthritis & Osteoporosis Medical Clinic — San Diego, California, United States
• 'San Francisco General Hospital — San Francisco, California, United States
• 'Community Research Centers — Santa Ana, California, United States
• 'Denver Arthritis Clinic — Denver, Colorado, United States
• 'Colorado Center for Bone Research — Lakewood, Colorado, United States
• 'Longmont Medical Research Network — Longmont, Colorado, United States
• 'Northeast Clinical Research, LLC — Hamden, Connecticut, United States
• 'Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• 'RASF - Clinical Research Center — Boca Raton, Florida, United States
• 'ICSL Clinical Studies — Fort Myers, Florida, United States
• 'The Center for Diabetes and Endocrine Care — Hollywood, Florida, United States
• 'Florida Wellcare Alliance — Inverness, Florida, United States
• Capstone Clinical Trials — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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