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OsteoporosisPhase 3NCT00172081

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

A Phase 3 study testing ALX1-11 in people with Osteoporosis, run by Shire at 174 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 45 years and older, women only
Conditions the study is for
Osteoporosis
What is being tested?
ALX1-11
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,532 participants
Where
174 sitesin 9 countries
Study dates
27 Apr 2000to 7 Nov 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
  • DXA Imaging:
  • Inability to have a DXA scan performed.
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  • 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.
  • 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)
  • Anabolic steroids or androgens (6 consecutive months)
  • Active vitamin D3 metabolites and analogs(90 days)
  • Systemic corticosteroids, more than 5 mg/day prednisone or a systemic corticosteroid formulation equivalent to 5 mg/day prednisone (12 consecutive months).
  • A patient who has been enrolled in the study 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 is limited to no more than 30 consecutive days
  • The maximal dose of steroid (prednisone equivalent) is 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 treatment period of the study
  • Daily inhaled corticosteroids unless dose is below 1200 mg/day of beclomethasone.
  • Bisphosphonates, including investigational bisphosphonates.
  • Intravenous (IV) pamidronate. Patient must be receiving pamidronate specifically to treat osteoporosis. Patient can have received only ONE IV dose of pamidronate in the 12 months immediately preceding the screening visit.
  • Cyclical etidronate. Exposure to cyclical etidronate must be less than or equal to 6 months on a standard dose (e.g. 400 mg/day). Patient should not have exposure to cyclical etidronate for 9 months prior to the screening visit.
  • Phenytoin for seizure control. If the patient has received phenytoin within five years of the screening visit, the patient is excluded from this study. The patient may continue in the screening process if 15 years have passed since the last dose of phenytoin at the time of the screening visit. If the phenytoin use was between 5-15 years before the screening visit and the patient received phenytoin for less than 2 months.
  • Patients may be enrolled 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. * Stable dosage of thiazide for at least 3 consecutive months.
  • All patients must stop the following therapies at least 4 weeks prior to the screening visit and remain off these therapies for the remainder of the clinical trial. Screening laboratories must be performed after the washout is complete. However, imaging studies (BMD, X-rays) may be performed prior to starting the calcitonin, estrogen, and selective estrogen receptor modulation (SERM) washout.
  • 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* Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., remicade [infliximab])
  • The drug class tetracyclines
  • Medication known to affect the metabolism of bone (the Principal Investigator should discuss this with the Project Medical Officer before the patient is excluded from enrollment)
  • Miscellaneous Concurrent Medications:
  • Methotrexate
  • Intra-articular injections - Patients with chronic, active joint disease should be excluded from this Phase III study. Patients may receive a maximum of one intra-articular injection (ONE JOINT ONLY) every 6 months while participating in this Phase III study. 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.
  • Laboratory Values and Physical Examination Findings:
  • Serum calcium greater than 10.7 mg/dL (2.66 mmol/L). At screening, if the serum calcium is abnormal, the patient may have the additional evaluation described below ONCE:
  • Discontinue all oral calcium and vitamin D3 supplements.
  • Repeat a fasting serum calcium level two weeks later.
  • If the fasting serum calcium level is still abnormal, the patient is discontinued from the study.
  • If the repeat fasting serum calcium is normal, the patient should have supplemental calcium and vitamin D3 restarted at the time of study drug dosing, without going through a two-week stabilization period.
  • Serum creatinine > 1.5 mg/dL (132.6 mmol/L)
  • Urinary calcium to creatinine ratio is greater than or equal to 1. At screening, if a patient's urinary calcium to creatinine ratio is abnormal, the patient may have the additional evaluation described below ONCE:
  • Discontinue all oral calcium and vitamin D3 supplements.
  • Repeat a fasting urine calcium to creatinine ratio two weeks later.
  • If the fasting urinary calcium to creatinine ratio is still abnormal, the patient is discontinued from the study.
  • If the repeat fasting urinary calcium to creatinine ratio is normal, the patient should have supplemental calcium and vitamin D3 restarted at the time of study drug dosing, without going through a two-week stabilization period.
  • Total serum alkaline phosphatase >130 U/L except as noted - Argentina (311 U/L); Brazil (278 U/L); Mexico (159 U/L).
  • Any other clinically significant abnormal value as judged by the investigator
  • Body weight below 40 kg
  • Substance Abuse:
  • Alcohol and/or drug abuse
  • Psychiatric Disease:
  • Current or history of psychiatric disease that would interfere with the ability to comply with the clinical trial protocol
  • Compliance:
  • Suspected or confirmed poor compliance in completing clinical trial evaluations and/or clinical trial required questionnaires

Trial locations and contacts

174 sites in 9 countries.

174 sites in 9 countries

United States107 sites

  • 'New Mexico Clinical Research and Osteoporosis Center

    Albuquerque, New Mexico, 87106

  • 'Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • 'Robin K. Dore, M.D., Inc.

    Anaheim, California, 92801

  • 'Radiant Research

    Anderson, South Carolina, 29621

  • 'The Emory Clinic

    Atlanta, Georgia, 30322

  • 'Maine Center for Osteoporosis Research & Education

    Bangor, Maine, 04401

  • 'Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • 'Bethesda Health Research Center

    Bethesda, Maryland, 20817

  • 'Osteoporosis Medical Center

    Beverly Hills, California, 90211

  • Capstone Clinical Trials

    Birmingham, Alabama, 35205

  • 'The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • 'Odyssey Research Services

    Bismarck, North Dakota, 58501

  • 'ICSL-Clinical Studies

    Bloomington, Illinois, 61704

  • 'RASF - Clinical Research Center

    Boca Raton, Florida, 33486

  • 'Intermountain Orthopaedics

    Boise, Idaho, 83702

  • 'Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • 'Fletcher Allan Health Center, UHC Campus 1

    Burlington, Vermont, 05401

  • 'Carolina Bone and Joint - Charlotte

    Charlotte, North Carolina, 28210

  • 'Clinsearch

    Chattanooga, Tennessee, 37404

  • Rush-Prebyterian-St.Luke's Medical Center

    Chicago, Illinois, 60612

  • 'The University of Chicago

    Chicago, Illinois, 60637

  • 'Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • 'Columbia Arthritis Center, PA

    Columbia, South Carolina, 29204

  • 'East Bay Clinical Trial Center

    Concord, California, 94520

  • 'Arthritis, Osteoporosis Muscle Skeletal Disease Center

    Concord, New Hampshire, 03301

  • 'The Osteoporosis and Clinical Trials Center

    Cumberland, Maryland, 21502

  • 'Radiant Research/Dallas

    Dallas, Texas, 75235

  • 'Denver Arthritis Clinic

    Denver, Colorado, 80220

  • 'Mercy Arthritis and Osteoporosis Center

    Des Moines, Iowa, 50322

  • 'Michigan Bone & Mineral Clinic

    Detroit, Michigan, 48236

  • 'Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • 'Duke University Medical Center

    Durham, North Carolina, 27710

  • 'Phase III Clinical Research

    Fall River, Massachusetts, 02720

  • Michael J. Lillestol

    Fargo, North Dakota, 58103

  • 'ICSL Clinical Studies

    Fort Myers, Florida, 33907

  • 'Arthritis & Osteoporosis Center of Maryland

    Frederick, Maryland, 21702

  • 'Altru Health Systems/Altru Research Center

    Grand Forks, North Dakota, 58201

  • 'Radiant Research

    Greer, South Carolina, 29651

  • 'The Osteoporosis and Clinical Trials Center

    Hagerstown, Maryland, 21740

  • 'Northeast Clinical Research, LLC

    Hamden, Connecticut, 06518

  • 'The Center for Diabetes and Endocrine Care

    Hollywood, Florida, 33021

  • 'Radiant Research

    Honolulu, Hawaii, 96814

  • 'Breco Research Inc.

    Houston, Texas, 77024

  • 'Rheumatology Associates of North Alabama

    Huntsville, Alabama, 35801

  • 'University Hospital & Outpatient Center

    Indianapolis, Indiana, 46202

  • 'Florida Wellcare Alliance

    Inverness, Florida, 34452

  • 'Radiant Research - Lake Worth

    Lake Worth, Florida, 33461

  • 'Colorado Center for Bone Research

    Lakewood, Colorado, 80227

  • 'VA Southern NV Healthcare Systems

    Las Vegas, Nevada, 89106

  • 'Loma Linda Osteoporosis Research Center

    Loma Linda, California, 92354

  • 'Longmont Medical Research Network

    Longmont, Colorado, 80501

  • 'University of Wisconsin Medical Foundation

    Madison, Wisconsin, 53792

  • 'David R. Mandel M.D. Inc.

    Mayfield, Ohio, 44143

  • 'Osteoporosis Center

    Medford, Oregon, 97504

  • 'Osteoporosis Center University of Miami

    Miami, Florida, 33136

  • 'Diabetes Center of the Southwest

    Midland, Texas, 79705

  • 'Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • 'Bone Mineral Research Center

    Mineola, New York, 11501

  • 'Odyssey Research Services

    Minot, North Dakota, 58701

  • 'Ochsner Clinic

    New Orleans, Louisiana, 70121

  • 'Beth Israël Medical Center

    New York, New York, 10003

  • 'College of Physicians and Surgeons, Columbia University

    New York, New York, 10032

  • 'Center for Arthritis and Diabetes

    Newport News, Virginia, 23606

  • 'The Foundation for Osteoporosis Research and Education

    Oakland, California, 94612

  • 'Renstar Medical Group

    Ocala, Florida, 34471

  • 'Desoto Family Medical Center

    Olive Branch, Mississippi, 38654

  • 'South Puget Sound Clinical Research Center

    Olympia, Washington, 98502

  • 'Diabetes and Endocrinology Treatment Center

    Palm Beach Gardens, Florida, 33410

  • 'Desert Medical Advances

    Palm Desert, California, 92260

  • 'The Arthritis Center

    Palm Harbor, Florida, 34684

  • 'VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • 'Thomas Jefferson University

    Philadelphia, Pennsylvania, 19131

  • 'Radiant Research - Phoenix

    Phoenix, Arizona, 85013

  • 'University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • 'Rhode Island Hospital

    Providence, Rhode Island, 02903

  • 'Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • 'Boling Clinical Trials

    Rancho Cucamonga, California, 91730

  • 'Rapid City Medical Center

    Rapid City, South Dakota, 57701

  • 'National Clinical Research, Inc.

    Richmond, Virginia, 23294

  • 'MCV Physicians Program for Osteoporosis

    Richmond, Virginia, 23298

  • 'Rochester Clinical Research Inc.

    Rochester, New York, 14609

  • 'Diabetes & Glandular Disease Research Associates, P.A.

    San Antonio, Texas, 78229

  • 'Radiant Research San Antonio

    San Antonio, Texas, 78229

  • 'Radiant Research - San Diego

    San Diego, California, 92108

  • 'S.D. Arthritis & Osteoporosis Medical Clinic

    San Diego, California, 92120

  • 'San Francisco General Hospital

    San Francisco, California, 94110

  • 'Salt Lake Women's Center

    Sandy City, Utah, 84070

  • 'Community Research Centers

    Santa Ana, California, 92701

  • Phillip J. Mease

    Seattle, Washington, 98104

  • 'Osteoporosis Research Group

    Seattle, Washington, 98105

  • 'Averna Research Institute

    Sioux Falls, South Dakota, 57105

  • 'The Centre for Arthritis and Rheumatic Diseases

    South Miami, Florida, 33143

  • 'Anderson and Collins Clinical Research Inc.

    South Plainfield, New Jersey, 07080

  • 'St. John's Medical Research Group

    Springfield, Missouri, 65807

  • 'ICSL Clinical Studies

    St. Petersburg, Florida, 33702

  • 'Stony Brook Clinical Research Trials Center

    Stony Brook, New York, 11794

  • 'Radiant Research - Stuart & LakeWorth

    Stuart, Florida, 34996

  • 'Oklahoma Center for Arthritis Therapy & Research, Inc.

    Tulsa, Oklahoma, 74114

  • 'Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • 'Brown Clinic

    Watertown, South Dakota, 57201

  • 'Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • 'Clinical Research Center of Reading LLP

    West Reading, Pennsylvania, 19611

  • 'The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • 'Physicians Clinical Research Services

    White Plains, New York, 10605

  • 'Wichita Clinic

    Wichita, Kansas, 67208

  • 'Osteoporosis Research & Treatment Center

    Worcester, Massachusetts, 01605

  • 'Radiant Research

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada22 sites

  • 'Heritage Medical Research Clinic

    Calgary, Alberta, 'T2N 4N1

  • 'Riverside Medical Centre

    Charlottetown, Prince Edward Island, C1A 6A4

  • 'Complexe Hospitalier de la Sagami

    Chicoutimi, Quebec, G7H 5H6

  • Charlton Medical Centre

    Hamilton, Ontario, L8N 1Y2

  • Rafat Faraawi

    Kitchener, Ontario, N2M 5N6

  • 'Centre for Activity and Aging

    London, Ontario, 'N6G 2M3

  • St. Joseph's Health Centre

    London, Ontario, N6A 4V2

  • 'Royal Victoria Hospital

    Montreal, Ontario, 'H3A 1A1

  • 'Centre d'Etude Clinique Montreal Inc.

    Montreal, Quebec, 'H1T 1P6

  • 'Hopital Maisonneuve-Rosemont

    Montreal, Quebec, 'H1T 2M4

  • 'Centre de Recherche du CHUM - Hopital Saint-Luc

    Montreal, Quebec, 'H2X 1P1

  • Oakville Bone Center

    Oakville, Ontario, L6J 1X8

  • Ottawa Hospital

    Ottawa, Ontario, 'K1H 8L6

  • Centre de Recherche - CORQ

    Sainte-Foy, Quebec, G1V 3M7

  • 'Saskatoon Osteoporosis Centre

    Saskatoon, Saskatchewan, 'S7K 0H6

  • Novabyss Research Clinic

    Sherbrooke, Quebec, J1J 2B8

  • 'Sunnybrook and Women's College Health Science Center

    Toronto, Ontario, 'M4N 3M5

  • 'St. Michael's Hospital

    Toronto, Ontario, 'M5C 2T2

  • 'Osteoporosis Research Program

    Toronto, Ontario, 'M5S 1B2

  • Osteoporosis Research Center

    Vancouver, British Columbia, V5Z 2N6

  • Jude F. Rodrigues

    Windsor, Ontario, N8W 5L7

  • 'Manitoba Clinic

    Winnipeg, Manitoba, 'R3A 1M3

Other trials in Canada

Mexico11 sites

  • 'Hospital Clinical del Parque

    Chihuahua City, CHIH, 31020

  • 'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca

    Guadalajara, Jalisco, 44340

  • 'Hospital Civil de Belem

    Guadalajara, Jalisco, 44650

  • 'Medica Monraz

    Guadalajara, Jalisco, 44670

  • 'Hospital Angeles de las Lomas

    Huixquilucan, EMEX, 52763

  • 'Hospital Aranda de la Parra

    León, Guanajuato, 37000

  • 'Osteosol

    Mexico City, Mexico City, 06100

  • 'Instituto Mexicano de Investigacion Clinica

    Mexico City, Mexico City, 06700

  • 'Hospital de Mexico

    Mexico City, Mexico City, 11800

  • 'Hospital Universitario de Monterrey

    Monterrey Nuevo Leon, 64040

  • 'Hospital Central "Ignacio Morones Prieto"

    San Luis Potosí City, San Luis Potosí, 78240

Other trials in Mexico

Brazil10 sites

  • 'UNICAMP

    Campinas, São Paulo, 13083

  • 'Pontifícia Universidade Católica de Campinas

    Campinas, São Paulo

  • 'Universidade Federal do Paraná

    Curitiba, Paraná, 80060

  • 'Universidade Federal de Pernambuco

    Recife, Pernambuco, 50670

  • 'Hospital Santa Casa de Misericórdia do Rio de Janeiro

    Rio de Janeiro, Rio de Janeiro, 20020

  • 'Hospital do Servidor Público do Rio de Janeiro

    Rio de Janeiro, Rio de Janeiro, 20221

  • 'Hospital Santa Casa de Misericórdia de São Paulo

    São Paulo, São Paulo, 01221

  • 'Universidade Federal de São Paulo

    São Paulo, São Paulo, 04038

  • 'Instituto de Saúde e Bem Estar da Mulher

    São Paulo, São Paulo, 04062

  • 'Hospital Heliópolis

    São Paulo, São Paulo, 04231

Other trials in Brazil

Israel9 sites

  • 'Soroka Medical Center

    Beersheba, 84101

  • 'Clalit Health Services

    Beersheba, 84894

  • 'Hillel Yaffe Medical Center

    Hadera, 38101

  • 'Rambam Medical Center

    Haifa, 31096

  • 'Lin Medical Center

    Haifa, 34162

  • 'Hadassah University Hospital

    Jerusalem, 91240

  • 'Rabin Medical Center

    Petah Tikva, 49100

  • 'Chaim Sheba Medical Center

    Ramat Gan, 52621

  • 'Lis Maternity Hospital

    Tel Aviv

Other trials in Israel

Bulgaria5 sites

  • 'Multifunctional Hospital for Active Treatment "Sv.Georgy"

    Plovdiv, 4002

  • 'SHATENG"Acad.Ivan Penchev"

    Sofia, 1303

  • 'Multifunctional Hospital for Active Treatment "Alexandrovska

    Sofia, 1431

  • 'Multifunctional Hospital for Active Treatment "Sv.Ivan Rilsky"

    Sofia, 1431

  • 'SHATGO"Sheynovo"

    Sofia, 1504

Other trials in Bulgaria

Argentina4 sites

  • 'IDIM

    Buenos Aires, BUE, C1012AAR

  • 'Centro Médico T.I.E.M.P.O

    Buenos Aires, BUE, C1117ABH

  • 'Hospital Ramos Mejía

    Buenos Aires, BUE, C1221ADC

  • 'Centro de Osteopatias Medicas

    Capital Federal, CBA, C1114AAI

Other trials in Argentina

Romania3 sites

  • 'CLINTRIAL "DORIS" Medical Centre

    Bucharest, 772021

  • 'Centrul Medical Sabyc

    Bucharest

  • 'Spitalul Clinic Judetean Cluj-Napoca

    Cluj-Napoca, 3400

Other trials in Romania

Russia3 sites

  • 'Scientific Center of Endocrinology of RAMS

    Moscow, 117036

  • 'JK "Medicine"

    Moscow, 125047

  • 'Russian Academy for Advanced Medical Studies

    Moscow, 125315

Other trials in Russia

About this study

Official title: An 18-Month Double-Blind, Placebo-Controlled, Phase III, Trial With a 12-Month Interim Analysis of the Effect of Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

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.

Read the detailed description

Parathyroid hormone (PTH), a polypeptide consisting of 84 amino acids that is synthesized and secreted by the parathyroid glands, is a principal regulator of calcium homeostasis through concerted action on kidney, intestine and bone. Parathyroid hormone exerts its action on bone to release calcium into the extracellular fluid as a process of bone remodeling and also to maintain the serum calcium concentration, but the exact mechanisms are not fully understood. In some circumstances, PTH may exert an anabolic action on bone and can stimulate osteoblast proliferation and mature osteoblast function. The net effect of exogenous PTH administration on bone turnover depends on the pattern of delivery. A continuous long-term infusion gives a net decrease in trabecular bone volume, whereas daily single injections result in a net increase.

NPS Allelix Corp. is developing ALX1-11, recombinant human parathyroid hormone (1-84), for the treatment of osteoporosis. ALX1-11 is identical to the endogenous intact 84 amino acid human hormone and will be self-administered on a daily basis by subcutaneous (sc) injection.

Currently, there is no approved therapy for osteoporosis capable of stimulating the formation of new bone of normal composition and structure. Most therapies in development are anti-catabolic and only prevent further bone loss (e.g., estrogen replacement, bisphosphonates, and calcitonins). ALX1-11 has the potential to stimulate new bone formation in osteoporotic patients, thereby increasing bone mass and preventing fractures. Patients with moderately or severely reduced bone density and a fracture would be expected to benefit from treatment, thereby improving functional status and alleviating symptoms.

Conditions
Osteoporosis
Being tested
placebo, ALX1-11
Keywords
Post-menopausal, Osteoporosis, Parathyroid Hormone, PTH, ALX1-11
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    Daily subcutaneous injection with placebo

  • ALX1-11Drug

    Also called PREOS

    PTH (1-84) 100 mcg injected subcutaneously into the thigh or abdomen

Study groups in NCT00172081
Study groupRoleWhat they receive
placeboPlacebo comparatorDaily subcutaneous injection into thigh or abdomen with 700 mg Calcium and 400 IU Vitamin D daily
Receives: Drug: placebo
PTH(1-84) 100 mcgExperimentalSubcutaneous injection of PTH(1-84) with 700 mg Calcium and 400 IU Vitamin D daily
Receives: Drug: ALX1-11

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare effects of 18 months of treatment with ALX1-11/placebo on the incidence of new and/or worsened thoracic and lumbar vertebral fractures in postmenopausal women with osteoporosis receiving calcium and vitamin D3 supplements

    Measured: At Month 18

Secondary outcomes (1)

  1. Incidences of vertebral fractures at Month 12; hip and wrist fractures; and other clinical fractures.

    Measured: At Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study start27 Apr 2000
  3. Primary completion7 Nov 2003
  4. Study completion7 Nov 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00172081
Sponsor's protocol ID
ALX1-11-93001
Status last verified
May 2021
First submitted
9 Sep 2005
Last updated
14 May 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Greenspan SL, Bone HG, Ettinger MP, Hanley DA, Lindsay R, Zanchetta JR, Blosch CM, Mathisen AL, Morris SA, Marriott TB; Treatment of Osteoporosis with Parathyroid Hormone Study Group. Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med. 2007 Mar 6;146(5):326-39. doi: 10.7326/0003-4819-146-5-200703060-00005.

    PubMed 17339618

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALX1-11 in people with Osteoporosis, run by Shire at 174 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 71 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in United States, Canada, Mexico, Brazil, Israel and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare effects of 18 months of treatment with ALX1-11/placebo on the incidence of new and/or worsened thoracic and lumbar vertebral fractures in postmenopausal women with osteoporosis receiving calcium and vitamin D3 supplements (time frame: At Month 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00172081, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.

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