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FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0217, alendronate sodium / Duration of Treatment : 5 Years
Comparator : placebo (unspecified) /Duration of Treatment : 5 Years
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

60 Years - 86 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • To be eligible to participate in this study, women needed to have previously participated in the Fracture Intervention Trial (FIT) and to have been part of the group treated with alendronate in FIT
  • They needed to have received at least 3 years of treatment with alendronate in the FIT trial
  • In addition, their bone mineral density (BMD) at the hip needed to be better than it was at the start of FIT

Exclusion Criteria:

  • Patients were excluded if they had conditions that contraindicated alendronate therapy and if they might have used other medications for the treatment of osteoporosis
  • Women were also excluded if BMD at the hip was below a certain level (T-score <=-3.5); that is, if it were 3.5 standard deviations or more lower than the average for young adult women

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Total hip bone mineral density (BMD)

    Secondary Outcome Measures

    BMD of femoral neck, trochanter, and lumbar spine
    Biochemical markers of bone turnover

    Full Information

    First Posted
    November 10, 2006
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00398931
    Brief Title
    FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)
    Official Title
    A 5-year, Double-blind, Randomized, Placebo-controlled Extension Study to Examine the Long-term Safety and Efficacy of Oral Alendronate in Postmenopausal Women Who Previously Received Alendronate in Conjunction With the Fracture Intervention Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1998 (undefined)
    Primary Completion Date
    October 2003 (Actual)
    Study Completion Date
    October 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    This study was conducted among women who had previously received alendronate for 3 to 6 years during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly assigned to receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5 years, in order to evaluate the effects of continuing or discontinuing alendronate treatment on bone mineral density and biochemical markers of bone turnover.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Postmenopausal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1099 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0217, alendronate sodium / Duration of Treatment : 5 Years
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator : placebo (unspecified) /Duration of Treatment : 5 Years
    Primary Outcome Measure Information:
    Title
    Total hip bone mineral density (BMD)
    Secondary Outcome Measure Information:
    Title
    BMD of femoral neck, trochanter, and lumbar spine
    Title
    Biochemical markers of bone turnover

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    86 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be eligible to participate in this study, women needed to have previously participated in the Fracture Intervention Trial (FIT) and to have been part of the group treated with alendronate in FIT They needed to have received at least 3 years of treatment with alendronate in the FIT trial In addition, their bone mineral density (BMD) at the hip needed to be better than it was at the start of FIT Exclusion Criteria: Patients were excluded if they had conditions that contraindicated alendronate therapy and if they might have used other medications for the treatment of osteoporosis Women were also excluded if BMD at the hip was below a certain level (T-score <=-3.5); that is, if it were 3.5 standard deviations or more lower than the average for young adult women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17190893
    Citation
    Black DM, Schwartz AV, Ensrud KE, Cauley JA, Levis S, Quandt SA, Satterfield S, Wallace RB, Bauer DC, Palermo L, Wehren LE, Lombardi A, Santora AC, Cummings SR; FLEX Research Group. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA. 2006 Dec 27;296(24):2927-38. doi: 10.1001/jama.296.24.2927.
    Results Reference
    background
    PubMed Identifier
    8950879
    Citation
    Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996 Dec 7;348(9041):1535-41. doi: 10.1016/s0140-6736(96)07088-2.
    Results Reference
    background
    PubMed Identifier
    10695692
    Citation
    Bauer DC, Black D, Ensrud K, Thompson D, Hochberg M, Nevitt M, Musliner T, Freedholm D. Upper gastrointestinal tract safety profile of alendronate: the fracture intervention trial. Arch Intern Med. 2000 Feb 28;160(4):517-25. doi: 10.1001/archinte.160.4.517.
    Results Reference
    background
    PubMed Identifier
    11095442
    Citation
    Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg MC, Nevitt MC, Suryawanshi S, Cummings SR; Fracture Intervention Trial. Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab. 2000 Nov;85(11):4118-24. doi: 10.1210/jcem.85.11.6953. Erratum In: J Clin Endocrinol Metab 2001 Feb;86(2):938.
    Results Reference
    background
    PubMed Identifier
    11943033
    Citation
    Levis S, Quandt SA, Thompson D, Scott J, Schneider DL, Ross PD, Black D, Suryawanshi S, Hochberg M, Yates J; FIT Research Group. Alendronate reduces the risk of multiple symptomatic fractures: results from the fracture intervention trial. J Am Geriatr Soc. 2002 Mar;50(3):409-15. doi: 10.1046/j.1532-5415.2002.50102.x.
    Results Reference
    background
    PubMed Identifier
    15231011
    Citation
    Bauer DC, Black DM, Garnero P, Hochberg M, Ott S, Orloff J, Thompson DE, Ewing SK, Delmas PD; Fracture Intervention Trial Study Group. Change in bone turnover and hip, non-spine, and vertebral fracture in alendronate-treated women: the fracture intervention trial. J Bone Miner Res. 2004 Aug;19(8):1250-8. doi: 10.1359/JBMR.040512. Epub 2004 May 24.
    Results Reference
    background
    PubMed Identifier
    10714731
    Citation
    Cummings SR, Palermo L, Browner W, Marcus R, Wallace R, Pearson J, Blackwell T, Eckert S, Black D. Monitoring osteoporosis therapy with bone densitometry: misleading changes and regression to the mean. Fracture Intervention Trial Research Group. JAMA. 2000 Mar 8;283(10):1318-21. doi: 10.1001/jama.283.10.1318.
    Results Reference
    background
    PubMed Identifier
    9875874
    Citation
    Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, Palermo L, Prineas R, Rubin SM, Scott JC, Vogt T, Wallace R, Yates AJ, LaCroix AZ. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA. 1998 Dec 23-30;280(24):2077-82. doi: 10.1001/jama.280.24.2077.
    Results Reference
    background
    PubMed Identifier
    11069188
    Citation
    Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. doi: 10.1007/s001980070075.
    Results Reference
    background
    PubMed Identifier
    15231012
    Citation
    Ensrud KE, Barrett-Connor EL, Schwartz A, Santora AC, Bauer DC, Suryawanshi S, Feldstein A, Haskell WL, Hochberg MC, Torner JC, Lombardi A, Black DM; Fracture Intervention Trial Long-Term Extension Research Group. Randomized trial of effect of alendronate continuation versus discontinuation in women with low BMD: results from the Fracture Intervention Trial long-term extension. J Bone Miner Res. 2004 Aug;19(8):1259-69. doi: 10.1359/JBMR.040326. Epub 2004 Mar 29.
    Results Reference
    background
    PubMed Identifier
    10574584
    Citation
    Nevitt MC, Ross PD, Palermo L, Musliner T, Genant HK, Thompson DE. Association of prevalent vertebral fractures, bone density, and alendronate treatment with incident vertebral fractures: effect of number and spinal location of fractures. The Fracture Intervention Trial Research Group. Bone. 1999 Nov;25(5):613-9. doi: 10.1016/s8756-3282(99)00202-1.
    Results Reference
    background
    PubMed Identifier
    10366118
    Citation
    Hochberg MC, Ross PD, Black D, Cummings SR, Genant HK, Nevitt MC, Barrett-Connor E, Musliner T, Thompson D. Larger increases in bone mineral density during alendronate therapy are associated with a lower risk of new vertebral fractures in women with postmenopausal osteoporosis. Fracture Intervention Trial Research Group. Arthritis Rheum. 1999 Jun;42(6):1246-54. doi: 10.1002/1529-0131(199906)42:63.0.CO;2-U.
    Results Reference
    background
    PubMed Identifier
    15883637
    Citation
    Hochberg MC, Thompson DE, Black DM, Quandt SA, Cauley J, Geusens P, Ross PD, Baran D; FIT Research Group. Effect of alendronate on the age-specific incidence of symptomatic osteoporotic fractures. J Bone Miner Res. 2005 Jun;20(6):971-6. doi: 10.1359/JBMR.050104. Epub 2005 Jan 18.
    Results Reference
    background
    PubMed Identifier
    10632308
    Citation
    Nevitt MC, Thompson DE, Black DM, Rubin SR, Ensrud K, Yates AJ, Cummings SR. Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Fracture Intervention Trial Research Group. Arch Intern Med. 2000 Jan 10;160(1):77-85. doi: 10.1001/archinte.160.1.77.
    Results Reference
    background
    PubMed Identifier
    11932287
    Citation
    Hochberg MC, Greenspan S, Wasnich RD, Miller P, Thompson DE, Ross PD. Changes in bone density and turnover explain the reductions in incidence of nonvertebral fractures that occur during treatment with antiresorptive agents. J Clin Endocrinol Metab. 2002 Apr;87(4):1586-92. doi: 10.1210/jcem.87.4.8415.
    Results Reference
    background
    PubMed Identifier
    10733048
    Citation
    Ensrud KE, Thompson DE, Cauley JA, Nevitt MC, Kado DM, Hochberg MC, Santora AC 2nd, Black DM. Prevalent vertebral deformities predict mortality and hospitalization in older women with low bone mass. Fracture Intervention Trial Research Group. J Am Geriatr Soc. 2000 Mar;48(3):241-9. doi: 10.1111/j.1532-5415.2000.tb02641.x.
    Results Reference
    background
    PubMed Identifier
    15448985
    Citation
    Papapoulos SE, Quandt SA, Liberman UA, Hochberg MC, Thompson DE. Meta-analysis of the efficacy of alendronate for the prevention of hip fractures in postmenopausal women. Osteoporos Int. 2005 May;16(5):468-74. doi: 10.1007/s00198-004-1725-z. Epub 2004 Sep 21.
    Results Reference
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    PubMed Identifier
    10994823
    Citation
    Vogt TM, Ross PD, Palermo L, Musliner T, Genant HK, Black D, Thompson DE. Vertebral fracture prevalence among women screened for the Fracture Intervention Trial and a simple clinical tool to screen for undiagnosed vertebral fractures. Fracture Intervention Trial Research Group. Mayo Clin Proc. 2000 Sep;75(9):888-96. doi: 10.4065/75.9.888.
    Results Reference
    background
    PubMed Identifier
    15757015
    Citation
    Quandt SA, Thompson DE, Schneider DL, Nevitt MC, Black DM; Fracture Intervention Trial Research Group. Effect of alendronate on vertebral fracture risk in women with bone mineral density T scores of-1.6 to -2.5 at the femoral neck: the Fracture Intervention Trial. Mayo Clin Proc. 2005 Mar;80(3):343-9. doi: 10.4065/80.3.343.
    Results Reference
    background
    PubMed Identifier
    20200926
    Citation
    Schwartz AV, Bauer DC, Cummings SR, Cauley JA, Ensrud KE, Palermo L, Wallace RB, Hochberg MC, Feldstein AC, Lombardi A, Black DM; FLEX Research Group. Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. J Bone Miner Res. 2010 May;25(5):976-82. doi: 10.1002/jbmr.11.
    Results Reference
    result
    PubMed Identifier
    24798675
    Citation
    Bauer DC, Schwartz A, Palermo L, Cauley J, Hochberg M, Santora A, Cummings SR, Black DM. Fracture prediction after discontinuation of 4 to 5 years of alendronate therapy: the FLEX study. JAMA Intern Med. 2014 Jul;174(7):1126-34. doi: 10.1001/jamainternmed.2014.1232.
    Results Reference
    result

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    FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)

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