An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass
4. februar 2014 opdateret af: Genzyme, a Sanofi Company
A Phase I/II Randomized Study of the Short-Term Effects of APOMINE vs Placebo in Postmenopausal Women With Osteoporosis or Low Bone Mass
Osteoporosis affects millions of postmenopausal women in the USA.
The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass.
Another possible treatment consists of drugs that increase bone formation.
There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH).
Neither of these two drugs has been approved by the FDA.
APOMINE has shown significant bone formation in animal studies.
In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.
Studieoversigt
Detaljeret beskrivelse
This study is a randomized, placebo-controlled, double-blind, parallel-group study to investigate the efficacy and safety of administering 3 dose levels of APOMINE at 25, 50, or 100 mg/day or placebo once a day as a capsule to postmenopausal women with low bone mass or osteoporosis.
Eligible patients must be women between 45 and 75 years of age, have a diagnosed low bone mineral density or osteoporosis, and be at least 3 years post menopause.
The primary endpoint of the study will be changes in bone formation markers (bone alkaline phosphatase and osteocalcin).
The secondary endpoint of the study will be changes in bone formation markers (bone alkaline phosphatase, osteocalcin, and P-ICP) and bone resorption markers (serum C-telopeptide, urinary N-telopeptide).
Blood samples will be drawn at each study visit to determine these bone markers as well as for normal laboratory tests.
Bone mineral density measurements (DEXA) will be performed at the beginning and at the end of the study.
Up to 60 subjects will be randomized as a cohort for treatment and treated with 25, 50, or 100 mg/day or placebo (15 subjects per group).
All enrolled subjects will receive a daily calcium and Vitamin D supplement.
Undersøgelsestype
Interventionel
Tilmelding
60
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Nebraska
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Omaha, Nebraska, Forenede Stater
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New York
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West Haverstraw, New York, Forenede Stater
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- A diagnosis of osteoporosis or low bone mass (T score < or = to -1).
- Female, 45 to 75 years old (inclusive).
- Postmenopausal (cessation of menses or oophorectomy) by at least 3 years.
- Bone mineral density: (BMD) at spine or hip >1 standard deviation below mean for young normals of same sex (T score < or = to -1).
- Adequate liver function as indicated by a total bilirubin, AST, and ALT being within institutional normal limits.
- Serum creatinine within institutional normal limits.
- Signed, written informed consent.
- Able to comply with study procedures and follow-up examinations.
- Ionized calcium and 25-hydroxyvitamin D3 must be within institutional normal limits.
- PTH must be within institutional normal limits.
Exclusion Criteria:
- Known hypersensitivity to study drug or related compounds (e.g., bisphosphonates).
- Use of any drugs for treatment of osteoporosis in the previous 6 months (e.g., bisphosphonates, hormone-replacement therapy [HRT]).
- Any chronic or continued use of drugs that are known to affect bone metabolism (e.g., diuretics, glucocorticoids, oral contraceptives).
- Gallstone diagnosed within the past 5 years or a history of multiple gallstones.
- Previous significant gastrointestinal surgery (except appendectomy) or gastrointestinal disease.
- Abnormal thyroid function (by thyroid-stimulating hormone [TSH] assay, normal range 0.5-5.0 U/L).
- Secondary osteoporosis (e.g., steroid-induced) and/or any other disorder affecting calcium or mineral metabolism.
- Use of investigational agents within previous 30 days.
- Patients with existing heart problems (e.g., congestive heart failure, unstable angina, conduction delay).
- Patients taking calcium channel blockers, beta blockers, digitalis, or antihypertensive agents.
- Any other concurrent disease or condition that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Osteoporosis/low bone mass subjects treated with 3 levels (25, 50 or 100 mg/day) of Apomine or placebo. Efficacy measured by changes in baseline in: biochemical indicators of bone formation and bone resorption and BMD.
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Sekundære resultatmål
Resultatmål |
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To evaluate the quantitative and qualitative toxicities, as well as limited pharmacokinetics in this population.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2003
Studieafslutning
1. december 2004
Datoer for studieregistrering
Først indsendt
16. februar 2004
Først indsendt, der opfyldte QC-kriterier
18. februar 2004
Først opslået (Skøn)
19. februar 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. februar 2014
Sidst verificeret
1. februar 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APB-231
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