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

Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00172081
Collaborator
(none)
2,532
Enrollment
174
Locations
2
Arms
42.3
Actual Duration (Months)
14.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2532 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 27, 2000
Actual Primary Completion Date :
Nov 7, 2003
Actual Study Completion Date :
Nov 7, 2003

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo

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

Drug: placebo
Daily subcutaneous injection with placebo
Experimental: PTH(1-84) 100 mcg

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

Drug: ALX1-11
PTH (1-84) 100 mcg injected subcutaneously into the thigh or abdomen
Other Names:
  • PREOS

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:
    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)

    • 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:

    1. Exposure to steroids is limited to no more than 30 consecutive days

    2. The maximal dose of steroid (prednisone equivalent) is limited to no more than 225 mg (7.5 mg each day for 30 days)

    3. 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)

    E. 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.

    F. 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:

    1. Discontinue all oral calcium and vitamin D3 supplements.

    2. Repeat a fasting serum calcium level two weeks later.

    3. If the fasting serum calcium level is still abnormal, the patient is discontinued from the study.

    4. 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:

    1. Discontinue all oral calcium and vitamin D3 supplements.

    2. Repeat a fasting urine calcium to creatinine ratio two weeks later.

    3. If the fasting urinary calcium to creatinine ratio is still abnormal, the patient is discontinued from the study.

    4. 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

    G. Substance Abuse:
    • Alcohol and/or drug abuse
    H. Psychiatric Disease:
    • Current or history of psychiatric disease that would interfere with the ability to comply with the clinical trial protocol
    I. Compliance:
    • Suspected or confirmed poor compliance in completing clinical trial evaluations and/or clinical trial required questionnaires

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Capstone Clinical Trials Birmingham Alabama United States 35205
    2 'The University of Alabama at Birmingham Birmingham Alabama United States 35294
    3 'Rheumatology Associates of North Alabama Huntsville Alabama United States 35801
    4 'Radiant Research - Phoenix Phoenix Arizona United States 85013
    5 'Robin K. Dore, M.D., Inc. Anaheim California United States 92801
    6 'Osteoporosis Medical Center Beverly Hills California United States 90211
    7 'East Bay Clinical Trial Center Concord California United States 94520
    8 'Loma Linda Osteoporosis Research Center Loma Linda California United States 92354
    9 'The Foundation for Osteoporosis Research and Education Oakland California United States 94612
    10 'Desert Medical Advances Palm Desert California United States 92260
    11 'VA Palo Alto Health Care System Palo Alto California United States 94304
    12 'Boling Clinical Trials Rancho Cucamonga California United States 91730
    13 'Radiant Research - San Diego San Diego California United States 92108
    14 'S.D. Arthritis & Osteoporosis Medical Clinic San Diego California United States 92120
    15 'San Francisco General Hospital San Francisco California United States 94110
    16 'Community Research Centers Santa Ana California United States 92701
    17 'Denver Arthritis Clinic Denver Colorado United States 80220
    18 'Colorado Center for Bone Research Lakewood Colorado United States 80227
    19 'Longmont Medical Research Network Longmont Colorado United States 80501
    20 'Northeast Clinical Research, LLC Hamden Connecticut United States 06518
    21 'Georgetown University Medical Center Washington District of Columbia United States 20007
    22 'RASF - Clinical Research Center Boca Raton Florida United States 33486
    23 'ICSL Clinical Studies Fort Myers Florida United States 33907
    24 'The Center for Diabetes and Endocrine Care Hollywood Florida United States 33021
    25 'Florida Wellcare Alliance Inverness Florida United States 34452
    26 'Radiant Research - Lake Worth Lake Worth Florida United States 33461
    27 'Osteoporosis Center University of Miami Miami Florida United States 33136
    28 'Renstar Medical Group Ocala Florida United States 34471
    29 'Diabetes and Endocrinology Treatment Center Palm Beach Gardens Florida United States 33410
    30 'The Arthritis Center Palm Harbor Florida United States 34684
    31 'ICSL Clinical Studies Saint Petersburg Florida United States 33702
    32 'The Centre for Arthritis and Rheumatic Diseases South Miami Florida United States 33143
    33 'Radiant Research - Stuart & LakeWorth Stuart Florida United States 34996
    34 'Palm Beach Research Center West Palm Beach Florida United States 33409
    35 'The Emory Clinic Atlanta Georgia United States 30322
    36 'Radiant Research Honolulu Hawaii United States 96814
    37 'Intermountain Orthopaedics Boise Idaho United States 83702
    38 'ICSL-Clinical Studies Bloomington Illinois United States 61704
    39 Rush-Prebyterian-St.Luke's Medical Center Chicago Illinois United States 60612
    40 'The University of Chicago Chicago Illinois United States 60637
    41 'University Hospital & Outpatient Center Indianapolis Indiana United States 46202
    42 'Mercy Arthritis and Osteoporosis Center Des Moines Iowa United States 50322
    43 'Wichita Clinic Wichita Kansas United States 67208
    44 'Ochsner Clinic New Orleans Louisiana United States 70121
    45 'Maine Center for Osteoporosis Research & Education Bangor Maine United States 04401
    46 'Bethesda Health Research Center Bethesda Maryland United States 20817
    47 'The Osteoporosis and Clinical Trials Center Cumberland Maryland United States 21502
    48 'Arthritis & Osteoporosis Center of Maryland Frederick Maryland United States 21702
    49 'The Osteoporosis and Clinical Trials Center Hagerstown Maryland United States 21740
    50 'The Center for Rheumatology and Bone Research Wheaton Maryland United States 20902
    51 'Brigham & Women's Hospital Boston Massachusetts United States 02115
    52 'Phase III Clinical Research Fall River Massachusetts United States 02720
    53 'Osteoporosis Research & Treatment Center Worcester Massachusetts United States 01605
    54 'Michigan Bone & Mineral Clinic Detroit Michigan United States 48236
    55 'Desoto Family Medical Center Olive Branch Mississippi United States 38654
    56 'St. John's Medical Research Group Springfield Missouri United States 65807
    57 'VA Southern NV Healthcare Systems Las Vegas Nevada United States 89106
    58 'Arthritis, Osteoporosis Muscle Skeletal Disease Center Concord New Hampshire United States 03301
    59 'Comprehensive Clinical Research Berlin New Jersey United States 08009
    60 'Anderson and Collins Clinical Research Inc. South Plainfield New Jersey United States 07080
    61 'New Mexico Clinical Research and Osteoporosis Center Albuquerque New Mexico United States 87106
    62 'Lovelace Scientific Resources Albuquerque New Mexico United States 87108
    63 'Bone Mineral Research Center Mineola New York United States 11501
    64 'Beth Israël Medical Center New York New York United States 10003
    65 'College of Physicians and Surgeons, Columbia University New York New York United States 10032
    66 'Rochester Clinical Research Inc. Rochester New York United States 14609
    67 'Stony Brook Clinical Research Trials Center Stony Brook New York United States 11794
    68 'Physicians Clinical Research Services White Plains New York United States 10605
    69 'Carolina Bone and Joint - Charlotte Charlotte North Carolina United States 28210
    70 'Duke University Medical Center Durham North Carolina United States 27710
    71 'Odyssey Research Services Bismarck North Dakota United States 58501
    72 Michael J. Lillestol Fargo North Dakota United States 58103
    73 'Altru Health Systems/Altru Research Center Grand Forks North Dakota United States 58201
    74 'Odyssey Research Services Minot North Dakota United States 58701
    75 'Cleveland Clinic Foundation Cleveland Ohio United States 44195
    76 'David R. Mandel M.D. Inc. Mayfield Ohio United States 44143
    77 'Oklahoma Center for Arthritis Therapy & Research, Inc. Tulsa Oklahoma United States 74114
    78 'Osteoporosis Center Medford Oregon United States 97504
    79 'Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
    80 'Thomas Jefferson University Philadelphia Pennsylvania United States 19131
    81 'University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    82 'Clinical Research Center of Reading LLP West Reading Pennsylvania United States 19611
    83 'Radiant Research Wyomissing Pennsylvania United States 19610
    84 'Rhode Island Hospital Providence Rhode Island United States 02903
    85 'Roger Williams Medical Center Providence Rhode Island United States 02908
    86 'Radiant Research Anderson South Carolina United States 29621
    87 'Columbia Arthritis Center, PA Columbia South Carolina United States 29204
    88 'Radiant Research Greer South Carolina United States 29651
    89 'Rapid City Medical Center Rapid City South Dakota United States 57701
    90 'Averna Research Institute Sioux Falls South Dakota United States 57105
    91 'Brown Clinic Watertown South Dakota United States 57201
    92 'Clinsearch Chattanooga Tennessee United States 37404
    93 'Radiant Research/Dallas Dallas Texas United States 75235
    94 'Breco Research Inc. Houston Texas United States 77024
    95 'Diabetes Center of the Southwest Midland Texas United States 79705
    96 'Diabetes & Glandular Disease Research Associates, P.A. San Antonio Texas United States 78229
    97 'Radiant Research San Antonio San Antonio Texas United States 78229
    98 'Salt Lake Women's Center Sandy Utah United States 84070
    99 'Fletcher Allan Health Center, UHC Campus 1 Burlington Vermont United States 05401
    100 'Center for Arthritis and Diabetes Newport News Virginia United States 23606
    101 'National Clinical Research, Inc. Richmond Virginia United States 23294
    102 'MCV Physicians Program for Osteoporosis Richmond Virginia United States 23298
    103 'South Puget Sound Clinical Research Center Olympia Washington United States 98502
    104 Phillip J. Mease Seattle Washington United States 98104
    105 'Osteoporosis Research Group Seattle Washington United States 98105
    106 'University of Wisconsin Medical Foundation Madison Wisconsin United States 53792
    107 'Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    108 'IDIM Buenos Aires BUE Argentina C1012AAR
    109 'Centro Médico T.I.E.M.P.O Buenos Aires BUE Argentina C1117ABH
    110 'Hospital Ramos Mejía Buenos Aires BUE Argentina C1221ADC
    111 'Centro de Osteopatias Medicas Capital Federal CBA Argentina C1114AAI
    112 'Universidade Federal de Pernambuco Recife PE Brazil 50670
    113 'Universidade Federal do Paraná Curitiba PR Brazil 80060
    114 'Hospital Santa Casa de Misericórdia do Rio de Janeiro 'Rio de Janeiro RJ Brazil 20020
    115 'Hospital do Servidor Público do Rio de Janeiro Rio de Janeiro RJ Brazil 20221
    116 'UNICAMP Campinas SP Brazil 13083
    117 'Pontifícia Universidade Católica de Campinas Campinas SP Brazil
    118 'Hospital Santa Casa de Misericórdia de São Paulo Sao Paulo SP Brazil 01221
    119 'Universidade Federal de São Paulo Sao Paulo SP Brazil 04038
    120 'Instituto de Saúde e Bem Estar da Mulher Sao Paulo SP Brazil 04062
    121 'Hospital Heliópolis Sao Paulo SP Brazil 04231
    122 'Multifunctional Hospital for Active Treatment "Sv.Georgy" Plovdiv Bulgaria 4002
    123 'SHATENG"Acad.Ivan Penchev" Sofia Bulgaria 1303
    124 'Multifunctional Hospital for Active Treatment "Alexandrovska Sofia Bulgaria 1431
    125 'Multifunctional Hospital for Active Treatment "Sv.Ivan Rilsky" Sofia Bulgaria 1431
    126 'SHATGO"Sheynovo" Sofia Bulgaria 1504
    127 'Heritage Medical Research Clinic Calgary Alberta Canada 'T2N 4N1
    128 Osteoporosis Research Center Vancouver British Columbia Canada V5Z 2N6
    129 'Manitoba Clinic Winnipeg Manitoba Canada 'R3A 1M3
    130 Charlton Medical Centre Hamilton Ontario Canada L8N 1Y2
    131 Rafat Faraawi Kitchener Ontario Canada N2M 5N6
    132 'Centre for Activity and Aging London Ontario Canada 'N6G 2M3
    133 St. Joseph's Health Centre London Ontario Canada N6A 4V2
    134 'Royal Victoria Hospital Montreal Ontario Canada 'H3A 1A1
    135 Oakville Bone Center Oakville Ontario Canada L6J 1X8
    136 Ottawa Hospital Ottawa Ontario Canada 'K1H 8L6
    137 'Sunnybrook and Women's College Health Science Center Toronto Ontario Canada 'M4N 3M5
    138 'St. Michael's Hospital Toronto Ontario Canada 'M5C 2T2
    139 'Osteoporosis Research Program Toronto Ontario Canada 'M5S 1B2
    140 Jude F. Rodrigues Windsor Ontario Canada N8W 5L7
    141 'Riverside Medical Centre Charlottetown Prince Edward Island Canada C1A 6A4
    142 'Complexe Hospitalier de la Sagami Chicoutimi Quebec Canada G7H 5H6
    143 'Centre d'Etude Clinique Montreal Inc. Montreal Quebec Canada 'H1T 1P6
    144 'Hopital Maisonneuve-Rosemont Montreal Quebec Canada 'H1T 2M4
    145 'Centre de Recherche du CHUM - Hopital Saint-Luc Montreal Quebec Canada 'H2X 1P1
    146 Centre de Recherche - CORQ Sainte-Foy Quebec Canada G1V 3M7
    147 Novabyss Research Clinic Sherbrooke Quebec Canada J1J 2B8
    148 'Saskatoon Osteoporosis Centre 'Saskatoon Saskatchewan Canada 'S7K 0H6
    149 'Soroka Medical Center Beer Sheva Israel 84101
    150 'Clalit Health Services Beer Sheva Israel 84894
    151 'Hillel Yaffe Medical Center Hadera Israel 38101
    152 'Rambam Medical Center Haifa Israel 31096
    153 'Lin Medical Center Haifa Israel 34162
    154 'Hadassah University Hospital Jerusalem Israel 91240
    155 'Rabin Medical Center Petach Tikva Israel 49100
    156 'Chaim Sheba Medical Center Ramat Gan Israel 52621
    157 'Lis Maternity Hospital Tel Aviv Israel
    158 'Hospital Clinical del Parque Chihuahua Chih Mexico 31020
    159 'Osteosol Mexico DF Mexico 06100
    160 'Instituto Mexicano de Investigacion Clinica Mexico DF Mexico 06700
    161 'Hospital de Mexico Mexico DF Mexico 11800
    162 'Hospital Angeles de las Lomas 'Huixquilucan Emex Mexico 52763
    163 'Hospital Aranda de la Parra Leon GTO Mexico 37000
    164 'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca Guadalajara JAL Mexico 44340
    165 'Hospital Civil de Belem Guadalajara JAL Mexico 44650
    166 'Medica Monraz Guadalajara JAL Mexico 44670
    167 'Hospital Central "Ignacio Morones Prieto" 'San Luis Potosi SLP Mexico 78240
    168 'Hospital Universitario de Monterrey Monterrey Nuevo Leon Mexico 64040
    169 'CLINTRIAL "DORIS" Medical Centre Bucuresti Romania 772021
    170 'Centrul Medical Sabyc Bucuresti Romania
    171 'Spitalul Clinic Judetean Cluj-Napoca Cluj-Napoca Romania 3400
    172 'Scientific Center of Endocrinology of RAMS Moscow Russian Federation 117036
    173 'JK "Medicine" Moscow Russian Federation 125047
    174 'Russian Academy for Advanced Medical Studies Moscow Russian Federation 125315

    Sponsors and Collaborators

    • Shire

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT00172081
    Other Study ID Numbers:
    • ALX1-11-93001
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Shire
    Post-menopausal
    Osteoporosis
    Parathyroid Hormone
    PTH
    ALX1-11
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal

    Study Results

    No Results Posted as of May 14, 2021