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

NCT00172081 | Completed Phase 3 DMC

• 1 other identifier: ALX1-11-93001
• Study Type: interventional
• Target: 2,532
• Locations: 9 countries
• Sites: 174

Brief 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.

Conditions

Osteoporosis

Keywords

Post-menopausal; Osteoporosis; Parathyroid Hormone; PTH; ALX1-11

Outcome Measures

Primary Outcomes (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

  At Month 18

Secondary Outcomes (1)

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

  At Month 12

Study Arms (2)

placebo

PLACEBO COMPARATOR

Daily subcutaneous injection into thigh or abdomen with 700 mg Calcium and 400 IU Vitamin D daily

Drug: placebo

PTH(1-84) 100 mcg

EXPERIMENTAL

Subcutaneous injection of PTH(1-84) with 700 mg Calcium and 400 IU Vitamin D daily

Drug: ALX1-11

Interventions

placebo DRUG

Daily subcutaneous injection with placebo

placebo

ALX1-11 DRUG

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

Also known as: PREOS

PTH(1-84) 100 mcg

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Shire: lead

Study Sites (174)

Capstone Clinical Trials

Birmingham, Alabama, 35205, United States

Location

'The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

'Rheumatology Associates of North Alabama

Huntsville, Alabama, 35801, United States

Location

'Radiant Research - Phoenix

Phoenix, Arizona, 85013, United States

Location

'Robin K. Dore, M.D., Inc.

Anaheim, California, 92801, United States

Location

'Osteoporosis Medical Center

Beverly Hills, California, 90211, United States

Location

'East Bay Clinical Trial Center

Concord, California, 94520, United States

Location

'Loma Linda Osteoporosis Research Center

Loma Linda, California, 92354, United States

Location

'The Foundation for Osteoporosis Research and Education

Oakland, California, 94612, United States

Location

'Desert Medical Advances

Palm Desert, California, 92260, United States

Location

'VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

'Boling Clinical Trials

Rancho Cucamonga, California, 91730, United States

Location

'Radiant Research - San Diego

San Diego, California, 92108, United States

Location

'S.D. Arthritis & Osteoporosis Medical Clinic

San Diego, California, 92120, United States

Location

'San Francisco General Hospital

San Francisco, California, 94110, United States

Location

'Community Research Centers

Santa Ana, California, 92701, United States

Location

'Denver Arthritis Clinic

Denver, Colorado, 80220, United States

Location

'Colorado Center for Bone Research

Lakewood, Colorado, 80227, United States

Location

'Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

'Northeast Clinical Research, LLC

Hamden, Connecticut, 06518, United States

Location

'Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

'RASF - Clinical Research Center

Boca Raton, Florida, 33486, United States

Location

'ICSL Clinical Studies

Fort Myers, Florida, 33907, United States

Location

'The Center for Diabetes and Endocrine Care

Hollywood, Florida, 33021, United States

Location

'Florida Wellcare Alliance

Inverness, Florida, 34452, United States

Location

'Radiant Research - Lake Worth

Lake Worth, Florida, 33461, United States

Location

'Osteoporosis Center University of Miami

Miami, Florida, 33136, United States

Location

'Renstar Medical Group

Ocala, Florida, 34471, United States

Location

'Diabetes and Endocrinology Treatment Center

Palm Beach Gardens, Florida, 33410, United States

Location

'The Arthritis Center

Palm Harbor, Florida, 34684, United States

Location

'The Centre for Arthritis and Rheumatic Diseases

South Miami, Florida, 33143, United States

Location

'ICSL Clinical Studies

St. Petersburg, Florida, 33702, United States

Location

'Radiant Research - Stuart & LakeWorth

Stuart, Florida, 34996, United States

Location

'Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

'The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

'Radiant Research

Honolulu, Hawaii, 96814, United States

Location

'Intermountain Orthopaedics

Boise, Idaho, 83702, United States

Location

'ICSL-Clinical Studies

Bloomington, Illinois, 61704, United States

Location

Rush-Prebyterian-St.Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

'The University of Chicago

Chicago, Illinois, 60637, United States

Location

'University Hospital & Outpatient Center

Indianapolis, Indiana, 46202, United States

Location

'Mercy Arthritis and Osteoporosis Center

Des Moines, Iowa, 50322, United States

Location

'Wichita Clinic

Wichita, Kansas, 67208, United States

Location

'Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

'Maine Center for Osteoporosis Research & Education

Bangor, Maine, 04401, United States

Location

'Bethesda Health Research Center

Bethesda, Maryland, 20817, United States

Location

'The Osteoporosis and Clinical Trials Center

Cumberland, Maryland, 21502, United States

Location

'Arthritis & Osteoporosis Center of Maryland

Frederick, Maryland, 21702, United States

Location

'The Osteoporosis and Clinical Trials Center

Hagerstown, Maryland, 21740, United States

Location

'The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

'Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

'Phase III Clinical Research

Fall River, Massachusetts, 02720, United States

Location

'Osteoporosis Research & Treatment Center

Worcester, Massachusetts, 01605, United States

Location

'Michigan Bone & Mineral Clinic

Detroit, Michigan, 48236, United States

Location

'Desoto Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

'St. John's Medical Research Group

Springfield, Missouri, 65807, United States

Location

'VA Southern NV Healthcare Systems

Las Vegas, Nevada, 89106, United States

Location

'Arthritis, Osteoporosis Muscle Skeletal Disease Center

Concord, New Hampshire, 03301, United States

Location

'Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

'Anderson and Collins Clinical Research Inc.

South Plainfield, New Jersey, 07080, United States

Location

'New Mexico Clinical Research and Osteoporosis Center

Albuquerque, New Mexico, 87106, United States

Location

'Lovelace Scientific Resources

Albuquerque, New Mexico, 87108, United States

Location

'Bone Mineral Research Center

Mineola, New York, 11501, United States

Location

'Beth Israël Medical Center

New York, New York, 10003, United States

Location

'College of Physicians and Surgeons, Columbia University

New York, New York, 10032, United States

Location

'Rochester Clinical Research Inc.

Rochester, New York, 14609, United States

Location

'Stony Brook Clinical Research Trials Center

Stony Brook, New York, 11794, United States

Location

'Physicians Clinical Research Services

White Plains, New York, 10605, United States

Location

'Carolina Bone and Joint - Charlotte

Charlotte, North Carolina, 28210, United States

Location

'Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

'Odyssey Research Services

Bismarck, North Dakota, 58501, United States

Location

Michael J. Lillestol

Fargo, North Dakota, 58103, United States

Location

'Altru Health Systems/Altru Research Center

Grand Forks, North Dakota, 58201, United States

Location

'Odyssey Research Services

Minot, North Dakota, 58701, United States

Location

'Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

'David R. Mandel M.D. Inc.

Mayfield, Ohio, 44143, United States

Location

'Oklahoma Center for Arthritis Therapy & Research, Inc.

Tulsa, Oklahoma, 74114, United States

Location

'Osteoporosis Center

Medford, Oregon, 97504, United States

Location

'Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

'Thomas Jefferson University

Philadelphia, Pennsylvania, 19131, United States

Location

'University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

'Clinical Research Center of Reading LLP

West Reading, Pennsylvania, 19611, United States

Location

'Radiant Research

Wyomissing, Pennsylvania, 19610, United States

Location

'Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

'Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

'Radiant Research

Anderson, South Carolina, 29621, United States

Location

'Columbia Arthritis Center, PA

Columbia, South Carolina, 29204, United States

Location

'Radiant Research

Greer, South Carolina, 29651, United States

Location

'Rapid City Medical Center

Rapid City, South Dakota, 57701, United States

Location

'Averna Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

'Brown Clinic

Watertown, South Dakota, 57201, United States

Location

'Clinsearch

Chattanooga, Tennessee, 37404, United States

Location

'Radiant Research/Dallas

Dallas, Texas, 75235, United States

Location

'Breco Research Inc.

Houston, Texas, 77024, United States

Location

'Diabetes Center of the Southwest

Midland, Texas, 79705, United States

Location

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

San Antonio, Texas, 78229, United States

Location

'Radiant Research San Antonio

San Antonio, Texas, 78229, United States

Location

'Salt Lake Women's Center

Sandy City, Utah, 84070, United States

Location

'Fletcher Allan Health Center, UHC Campus 1

Burlington, Vermont, 05401, United States

Location

'Center for Arthritis and Diabetes

Newport News, Virginia, 23606, United States

Location

'National Clinical Research, Inc.

Richmond, Virginia, 23294, United States

Location

'MCV Physicians Program for Osteoporosis

Richmond, Virginia, 23298, United States

Location

'South Puget Sound Clinical Research Center

Olympia, Washington, 98502, United States

Location

Phillip J. Mease

Seattle, Washington, 98104, United States

Location

'Osteoporosis Research Group

Seattle, Washington, 98105, United States

Location

'University of Wisconsin Medical Foundation

Madison, Wisconsin, 53792, United States

Location

'Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

'IDIM

Buenos Aires, BUE, C1012AAR, Argentina

Location

'Centro Médico T.I.E.M.P.O

Buenos Aires, BUE, C1117ABH, Argentina

Location

'Hospital Ramos Mejía

Buenos Aires, BUE, C1221ADC, Argentina

Location

'Centro de Osteopatias Medicas

Capital Federal, CBA, C1114AAI, Argentina

Location

'Universidade Federal do Paraná

Curitiba, Paraná, 80060, Brazil

Location

'Universidade Federal de Pernambuco

Recife, Pernambuco, 50670, Brazil

Location

'Hospital Santa Casa de Misericórdia do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20020, Brazil

Location

'Hospital do Servidor Público do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20221, Brazil

Location

'UNICAMP

Campinas, São Paulo, 13083, Brazil

Location

'Pontifícia Universidade Católica de Campinas

Campinas, São Paulo, Brazil

Location

'Hospital Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221, Brazil

Location

'Universidade Federal de São Paulo

São Paulo, São Paulo, 04038, Brazil

Location

'Instituto de Saúde e Bem Estar da Mulher

São Paulo, São Paulo, 04062, Brazil

Location

'Hospital Heliópolis

São Paulo, São Paulo, 04231, Brazil

Location

'Multifunctional Hospital for Active Treatment "Sv.Georgy"

Plovdiv, 4002, Bulgaria

Location

'SHATENG"Acad.Ivan Penchev"

Sofia, 1303, Bulgaria

Location

'Multifunctional Hospital for Active Treatment "Alexandrovska

Sofia, 1431, Bulgaria

Location

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

Sofia, 1431, Bulgaria

Location

'SHATGO"Sheynovo"

Sofia, 1504, Bulgaria

Location

'Heritage Medical Research Clinic

Calgary, Alberta, 'T2N 4N1, Canada

Location

Osteoporosis Research Center

Vancouver, British Columbia, V5Z 2N6, Canada

Location

'Manitoba Clinic

Winnipeg, Manitoba, 'R3A 1M3, Canada

Location

Charlton Medical Centre

Hamilton, Ontario, L8N 1Y2, Canada

Location

Rafat Faraawi

Kitchener, Ontario, N2M 5N6, Canada

Location

'Centre for Activity and Aging

London, Ontario, 'N6G 2M3, Canada

Location

St. Joseph's Health Centre

London, Ontario, N6A 4V2, Canada

Location

'Royal Victoria Hospital

Montreal, Ontario, 'H3A 1A1, Canada

Location

Oakville Bone Center

Oakville, Ontario, L6J 1X8, Canada

Location

Ottawa Hospital

Ottawa, Ontario, 'K1H 8L6, Canada

Location

'Sunnybrook and Women's College Health Science Center

Toronto, Ontario, 'M4N 3M5, Canada

Location

'St. Michael's Hospital

Toronto, Ontario, 'M5C 2T2, Canada

Location

'Osteoporosis Research Program

Toronto, Ontario, 'M5S 1B2, Canada

Location

Jude F. Rodrigues

Windsor, Ontario, N8W 5L7, Canada

Location

'Riverside Medical Centre

Charlottetown, Prince Edward Island, C1A 6A4, Canada

Location

'Complexe Hospitalier de la Sagami

Chicoutimi, Quebec, G7H 5H6, Canada

Location

'Centre d'Etude Clinique Montreal Inc.

Montreal, Quebec, 'H1T 1P6, Canada

Location

'Hopital Maisonneuve-Rosemont

Montreal, Quebec, 'H1T 2M4, Canada

Location

'Centre de Recherche du CHUM - Hopital Saint-Luc

Montreal, Quebec, 'H2X 1P1, Canada

Location

Centre de Recherche - CORQ

Sainte-Foy, Quebec, G1V 3M7, Canada

Location

Novabyss Research Clinic

Sherbrooke, Quebec, J1J 2B8, Canada

Location

'Saskatoon Osteoporosis Centre

Saskatoon, Saskatchewan, 'S7K 0H6, Canada

Location

'Soroka Medical Center

Beersheba, 84101, Israel

Location

'Clalit Health Services

Beersheba, 84894, Israel

Location

'Hillel Yaffe Medical Center

Hadera, 38101, Israel

Location

'Rambam Medical Center

Haifa, 31096, Israel

Location

'Lin Medical Center

Haifa, 34162, Israel

Location

'Hadassah University Hospital

Jerusalem, 91240, Israel

Location

'Rabin Medical Center

Petah Tikva, 49100, Israel

Location

'Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

'Lis Maternity Hospital

Tel Aviv, Israel

Location

'Hospital Clinical del Parque

Chihuahua City, CHIH, 31020, Mexico

Location

'Hospital Angeles de las Lomas

Huixquilucan, EMEX, 52763, Mexico

Location

'Hospital Aranda de la Parra

León, Guanajuato, 37000, Mexico

Location

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

Guadalajara, Jalisco, 44340, Mexico

Location

'Hospital Civil de Belem

Guadalajara, Jalisco, 44650, Mexico

Location

'Medica Monraz

Guadalajara, Jalisco, 44670, Mexico

Location

'Osteosol

Mexico City, Mexico City, 06100, Mexico

Location

'Instituto Mexicano de Investigacion Clinica

Mexico City, Mexico City, 06700, Mexico

Location

'Hospital de Mexico

Mexico City, Mexico City, 11800, Mexico

Location

'Hospital Central "Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

'Hospital Universitario de Monterrey

Monterrey Nuevo Leon, 64040, Mexico

Location

'CLINTRIAL "DORIS" Medical Centre

Bucharest, 772021, Romania

Location

'Centrul Medical Sabyc

Bucharest, Romania

Location

'Spitalul Clinic Judetean Cluj-Napoca

Cluj-Napoca, 3400, Romania

Location

'Scientific Center of Endocrinology of RAMS

Moscow, 117036, Russia

Location

'JK "Medicine"

Moscow, 125047, Russia

Location

'Russian Academy for Advanced Medical Studies

Moscow, 125315, Russia

Location

Related Publications (1)

• 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.

  PMID: 17339618 DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: April 27, 2000
• Primary Completion: November 7, 2003
• Study Completion: November 7, 2003
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

BR (10); IL (9); US (107); ME (11); BU (5); CA (22); RO (3); RU (3); AR (4)