OsteoporosisPhase 3OLESNCT00172133
Open Label Extension Study of PREOS
A Phase 3 study testing ALX1-11 (drug) in people with Osteoporosis, run by Shire at 132 sites in 8 countries.
Trial 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 of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. 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 (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,683 participants
- Where
- 132 sitesin 8 countries
- Study dates
- 16 Oct 2001to 13 Apr 2005
- 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 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 51Show fewer
- 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.
- 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
- 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
- Substance Abuse:
- Alcohol and/or drug abuse
- Compliance:
- Suspected or confirmed poor compliance in completing clinical trial evaluations and/or clinical trial required questionnaires
Trial locations and contacts
132 sites in 8 countries.
132 sites in 8 countries
United States84 sites
'New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, 87106
'Lovelace Scientific Resources
Albuquerque, New Mexico, 87108
'Radiant Research
Anderson, South Carolina, 29621
'Maine Center for Osteoporosis Research & Education
Bangor, Maine, 04401
'Bethesda Health Research Center
Bethesda, Maryland, 20817
'Osteoporosis Medical Center
Beverly Hills, California, 90211
'The University of Alabama at Birmingham
Birmingham, Alabama, 35294
'Odyssey Research Services
Bismarck, North Dakota, 58501
'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
'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
'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
Michael J. Lillestol
Fargo, North Dakota, 58103
'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
'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
'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
'Diabetes Center of the Southwest
Midland, Texas, 79705
'Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
'Odyssey Research Services
Minot, North Dakota, 58701
'Ochsner Clinic
New Orleans, Louisiana, 70121
'College of Physicians and Surgeons, Columbia University
New York, New York, 10032
'Center for Arthritis and Diabetes
Newport News, Virginia, 23606
Foundation for Osteoporosis Research
Oakland, California, 94612
'Renstar Medical Group
Ocala, Florida, 34471
'Desoto Family Medical Center
Olive Branch, Mississippi, 38654
'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 North
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
'S.D. Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92120
'Radiant Research - San Diego
San Diego, California, 92123
'San Francisco General Hospital
San Francisco, California, 94110
'Salt Lake Women's Center
Sandy City, Utah, 84070
'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
'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
'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
'Radiant Research
Wyomissing, Pennsylvania, 19610
Canada21 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
'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
Mexico8 sites
'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
'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
Brazil6 sites
'Universidade Federal do Paraná
Curitiba, Paraná, 80060
'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
'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
Israel6 sites
'Soroka Medical Center
Beersheba, 84101
'Rambam Medical Center
Haifa, 31096
'Lin Medical Center
Haifa, 34162
'Hadassah University Hospital
Jerusalem, 91240
'Chaim Sheba Medical Center
Ramat Gan, 52621
'Lis Maternity Hospital
Tel Aviv
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
Russia2 sites
'Scientific Center of Endocrinology of RAMS
Moscow, 117036
'Russian Academy for Advanced Medical Studies
Moscow, 125315
About this study
Official title: An 18-Month Open Label Extension Study (OLES) of the Safety and Efficacy of Recombinant Human Parathyroid Hormone, rhPTH(1-84), ALX1-11, in Women With Postmenopausal Osteoporosis Who Participated in Protocol ALX1-11-93001 (TOP Study)
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 of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.
Read the 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 without any other treatment for osteoporosis. The anabolic effects of ALX1-11 in the lumbar vertebrae were statistically significant after the 12-month treatment period and more pronounced than any approved therapy. Additionally, animal studies have shown that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically.
The primary objective of this OLES is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001. A secondary objective is to assess the change in vertebral BMD and compare the changes observed in patients who received ALX1-11 or placebo in Protocol ALX1-11-93001.
Patients will receive 100 µg/day of ALX1-11 daily via subcutaneous injection in this study. Patients should continue the study drug dosing frequency they were following at the end of Protocol ALX1-11-93001.
To enhance their safety, all patients will continue to take their daily supplements of 700 mg calcium and 400 IU Vitamin D3 prior to and during this OLES. Patients whose calcium supplement was discontinued during Protocol ALX1-11-93001 should maintain that discontinuation during this OLES. However upon completion of ALX1-11 dosing in the OLES, oral calcium supplement at a dose of 700 mg each morning should be restarted and maintained for the remainder of the OLES. Additional supplemental calcium and/or Vitamin D3 will not be permitted. A daily multivitamin supplement may be taken during the study. However, the multivitamin must contain no more than 200 mg/day calcium and 400 IU/day Vitamin D3. Patients will be monitored for the development of hypercalcemia and/or hypercalciuria and managed as described in Appendices 4 and 5.
There will be a stopping rule in this OLES. Any patient who reaches a BMD T score of -0.5 or above, at the site or sites (vertebral, total hip, or femoral neck) that were used in the qualification of the patient for Protocol ALX1 11-93001, will stop ALX1-11 treatment. The patient must continue on calcium and Vitamin D3 and be followed for the remainder of this 18-month OLES. At the time of discontinuation, the patient must complete the Month 18 evaluations (Appendix 1A or 1B).
The Clinical Advisory Board (CAB) used in Protocol ALX1-11-93001 will be involved in reviewing any patient issues that arise in this OLES. This group will provide not only continuity of care for all the patients, but also enhanced and consistent safety monitoring for patients participating in the OLES.
- Conditions
- Osteoporosis
- Being tested
- ALX1-11 (drug)
- 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.
ALX1-11 (drug)Drug
Also called PREOS
100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients entering the study will receive 100mcg daily for up to 6 months, making their total exposure 24 months Receives: Drug: ALX1-11 (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001 (TOP).
Measured: 24 months of treatment
Secondary outcomes (1)
To evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in BMD and other measures of bone quality and strength.
Measured: 24 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start16 Oct 2001
- Primary completion13 Apr 2005
- Study completion13 Apr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172133
- Sponsor's protocol ID
- CL1-11-002
- Acronym
- OLES
- Status last verified
- May 2021
- First submitted
- 12 Sep 2005
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 18-Month Open Label Extension Study (OLES) of the Safety and Efficacy of Recombinant Human Parathyroid Hormone, rhPTH(1-84), ALX1-11, in Women With Postmenopausal Osteoporosis Who Participated in Protocol ALX1-11-93001 (TOP Study)
- ClinicalTrials.gov ID
- NCT00172133
- Acronym / sponsor ID
- OLES / CL1-11-002
- Conditions
- Osteoporosis
- Keywords
- Post-menopausal, Osteoporosis, Parathyroid Hormone, PTH, ALX1-11
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,683 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2001 (actual)
- Primary completion
- 13 Apr 2005 (actual)
- Study completion
- 13 Apr 2005 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.
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 without any other treatment for osteoporosis. The anabolic effects of ALX1-11 in the lumbar vertebrae were statistically significant after the 12-month treatment period and more pronounced than any approved therapy. Additionally, animal studies have shown that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically.
The primary objective of this OLES is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001. A secondary objective is to assess the change in vertebral BMD and compare the changes observed in patients who received ALX1-11 or placebo in Protocol ALX1-11-93001.
Patients will receive 100 µg/day of ALX1-11 daily via subcutaneous injection in this study. Patients should continue the study drug dosing frequency they were following at the end of Protocol ALX1-11-93001.
To enhance their safety, all patients will continue to take their daily supplements of 700 mg calcium and 400 IU Vitamin D3 prior to and during this OLES. Patients whose calcium supplement was discontinued during Protocol ALX1-11-93001 should maintain that discontinuation during this OLES. However upon completion of ALX1-11 dosing in the OLES, oral calcium supplement at a dose of 700 mg each morning should be restarted and maintained for the remainder of the OLES. Additional supplemental calcium and/or Vitamin D3 will not be permitted. A daily multivitamin supplement may be taken during the study. However, the multivitamin must contain no more than 200 mg/day calcium and 400 IU/day Vitamin D3. Patients will be monitored for the development of hypercalcemia and/or hypercalciuria and managed as described in Appendices 4 and 5.
There will be a stopping rule in this OLES. Any patient who reaches a BMD T score of -0.5 or above, at the site or sites (vertebral, total hip, or femoral neck) that were used in the qualification of the patient for Protocol ALX1 11-93001, will stop ALX1-11 treatment. The patient must continue on calcium and Vitamin D3 and be followed for the remainder of this 18-month OLES. At the time of discontinuation, the patient must complete the Month 18 evaluations (Appendix 1A or 1B).
The Clinical Advisory Board (CAB) used in Protocol ALX1-11-93001 will be involved in reviewing any patient issues that arise in this OLES. This group will provide not only continuity of care for all the patients, but also enhanced and consistent safety monitoring for patients participating in the OLES.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ALX1-11 (drug)All patients entering the study will receive 100mcg daily for up to 6 months, making their total exposure 24 months |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (51 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALX1-11 (drug)Also: PREOS100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen. | Drug | 1 |
Primary outcome
To evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001 (TOP).
Time frame: 24 months of treatment
1 secondary outcome
To evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in BMD and other measures of bone quality and strength.
Time frame: 24 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
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Bone Health in Adults With Duchenne Muscular Dystrophy: A Survey on Osteoporosis, Fractures and Treatment.
Duchenne Muscular Dystrophy (DMD)
RecruitingObservational study
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
Osteoporosis Diagnosis, Bone Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
132 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALX1-11 (drug) in people with Osteoporosis, run by Shire at 132 sites in 8 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 10 inclusion and 51 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 17 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 132 sites in United States, Canada, Mexico, Brazil, Israel and 3 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. 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?
To evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001 (TOP). (time frame: 24 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2021.