Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women

Back to Search
Print
Bookmark Trial

NCT00481169

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.

- Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- One (1) or more osteoporotic vertebral fractures (T4-L4).


- Diseases that may affect bone metabolism.


- Past history or active nontraumatic venous thromboembolic events, including deep vein
thrombosis, pulmonary embolism, and retinal vein thrombosis.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

OsteoporosisViviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
NCT01470326
Female
0+
years
MULTIPLE SITES
OsteoporosisPost Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
NCT01793142
  1. Haeundae-gu, Busan
  2. Seoul, Capital Metropolitan
  3. Cheonan-si, Chuncheongnam-do
  4. Wonju-Si, Gangwon-do
  5. Gyeongju-si, Gyeongbuk
  6. Anyang-si, Gyeonggi-do
  7. Bucheon-Si, Gyeonggi-do
  8. Bucheon-Si, Gyeonggi-do
  9. Goyang-si, Gyeonggi-do
  10. Goyang-si, Gyeonggi-do
  11. Goyang-si, Gyeonggi-do
  12. Goyang-Si, Gyeonggi-do
  13. Goyang-si, Gyeonggi-do
  14. Goyang, Gyeonggi-do
  15. Gunpo-si, Gyeonggi-do
  16. Guri-si, Gyeonggi-do
  17. Seongnam-si, Gyeonggi-do
  18. Suwon-si, Gyeonggi-do
  19. Suwon-si, Gyeonggi-do
  20. Jinju-si, Gyeongsangnam-do
  21. Yangsan-si, Gyeongsangnam-do
  22. Iksan-si, Jeollabuk-do
  23. Seoul, Korea
  24. Daejeon, Republic OF Korea
  25. Seoul, Seodaemun-gu
  26. Daebang-dong, Seoul
  27. Seongdong-ku, Seoul
  28. Busan,
  29. Busan,
  30. Busan,
  31. Daegu,
  32. Daegu,
  33. Daejeon,
  34. Daejeon,
  35. Gangwon-do,
  36. Goyang-si,
  37. Gwangju-si,
  38. Gyoungju,
  39. Incheon,
  40. Incheon,
  41. Seoul,
  42. Seoul,
  43. Seoul,
  44. Seoul,
  45. Seoul,
  46. Seoul,
  47. Seoul,
  48. Seoul,
  49. Seoul,
  50. Seoul,
  51. Seoul,
  52. Seoul,
  53. Seoul,
  54. Seoul,
  55. Seoul,
  56. Seoul,
  57. Seoul,
  58. Seoul,
  59. Seoul,
  60. Seoul,
Female
0+
years
MULTIPLE SITES
OsteoporosisStudy Evaluating Changes In Mammographic Breast Density
NCT00774267
  1. Ft. Myers, Florida
  2. Gainesville, Florida
  3. New Port Richey, Florida
  4. West Palm Beach, Florida
  5. Decatur, Georgia
  6. Chicago, Illinois
  7. Lexington, Kentucky
  8. Lousiville, Kentucky
  9. Southfield, Michigan
  10. Chaska, Minnesota
  11. Billings, Montana
  12. Las Vegas, Nevada
  13. New Brunswick, New Jersey
  14. Rochester, New York
  15. Raleigh, North Carolina
  16. Cincinnati, Ohio
  17. Wexford, Pennsylvania
  18. Greenville, South Carolina
  19. Dallas, Texas
  20. San Antonio, Texas
  21. Charlottesville, Virginia
  22. Norfolk, Virginia
  23. Sao Paulo, RS/Brazil
  24. Nijmegen,
  25. Bergen,
  26. Hamar,
Female
40 Years+
years
MULTIPLE SITES
OsteoporosisStudy Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
NCT00205777
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Huntsville, Alabama
  5. Mobile, Alabama
  6. Glendale, Arizona
  7. Phoenix, Arizona
  8. Phoenix, Arizona
  9. Phoenix, Arizona
  10. Phoenix, Arizona
  11. Phoenix, Arizona
  12. Phoenix, Arizona
  13. Phoenix, Arizona
  14. Phoenix, Arizona
  15. Scottsdale, Arizona
  16. Scottsdale, Arizona
  17. Anaheim, California
  18. Berkeley, California
  19. Beverly Hills, California
  20. Fresno, California
  21. Fresno, California
  22. La Jolla, California
  23. Oakland, California
  24. Palm Desert, California
  25. Palm Springs, California
  26. Palm Springs, California
  27. Palm Springs, California
  28. Rancho Mirage, California
  29. Sacramento, California
  30. Sacramento, California
  31. Sacramento, California
  32. San Diego, California
  33. San Diego, California
  34. Upland, California
  35. Whittier, California
  36. Lakewood, Colorado
  37. Longmont, Colorado
  38. Wheat Ridge, Colorado
  39. Bridgeport, Connecticut
  40. Hamden, Connecticut
  41. Madison, Connecticut
  42. Waterbury, Connecticut
  43. Newark, Delaware
  44. Washington, District of Columbia
  45. Washington, District of Columbia
  46. Washington, District of Columbia
  47. Washington, District of Columbia
  48. Aventura, Florida
  49. Boca Raton, Florida
  50. Cape Coral, Florida
  51. Clearwater, Florida
  52. Daytona Beach, Florida
  53. Daytona Beach, Florida
  54. Delray Beach, Florida
  55. Fort Myers, Florida
  56. Ft. Myers, Florida
  57. Gainesville, Florida
  58. Holiday, Florida
  59. Lake Worth, Florida
  60. Largo, Florida
  61. Ormond Beach, Florida
  62. Palm Beach Gardens, Florida
  63. Palm Harbor, Florida
  64. Pembroke Pines, Florida
  65. Pembroke Pines, Florida
  66. Plantation, Florida
  67. Port Orange, Florida
  68. Sarasota, Florida
  69. Sarasota, Florida
  70. St Petersburg, Florida
  71. West Palm Beach, Florida
  72. West Palm Beach, Florida
  73. West Palm Beach, Florida
  74. West Palm Beach, Florida
  75. Augusta, Georgia
  76. Decatur, Georgia
  77. Riverdale, Georgia
  78. Boise, Idaho
  79. Boise, Idaho
  80. Boise, Idaho
  81. Cadwell, Idaho
  82. Idaho Falls, Idaho
  83. Meridian, Idaho
  84. Champaign, Illinois
  85. Chicago, Illinois
  86. Libertyville, Illinois
  87. Peoria, Illinois
  88. Avon, Indiana
  89. Evansville, Indiana
  90. Evansville, Indiana
  91. Evansville, Indiana
  92. Kansas City, Kansas
  93. Louisville, Kentucky
  94. Louisville, Kentucky
  95. Lousiville, Kentucky
  96. Bangor, Maine
  97. Bangor, Maine
  98. Bethesda, Maryland
  99. Silver Spring, Maryland
  100. Wheaton, Maryland
  101. Boston, Massachusetts
  102. Brookline, Massachusetts
  103. Fall River, Massachusetts
  104. Fall River, Massachusetts
  105. Grand Rapids, Michigan
  106. Grand Rapids, Michigan
  107. Kalamazaoo, Michigan
  108. Kalamazoo, Michigan
  109. Brooklyn Center, Minnesota
  110. Robbinsdale, Minnesota
  111. Shoreview, Minnesota
  112. Flowood, Mississippi
  113. Jackson, Mississippi
  114. Jefferson City, Missouri
  115. St Louis, Missouri
  116. St. Louis, Missouri
  117. Billings, Montana
  118. Bozeman, Montana
  119. Missoula, Montana
  120. Missoula, Montana
  121. Missoula, Montana
  122. Lincoln, Nebraska
  123. Henderson, Nevada
  124. North Las Vegas, Nevada
  125. Reno, Nevada
  126. Reno, Nevada
  127. Manchester Twp, New Jersey
  128. Ocean, New Jersey
  129. Princeton, New Jersey
  130. Albuquerque, New Mexico
  131. Albuquerque, New Mexico
  132. Albuquerque, New Mexico
  133. Bronx, New York
  134. New Hyde Park, New York
  135. New York, New York
  136. Charlotte, North Carolina
  137. Charlotte, North Carolina
  138. Charlotte, North Carolina
  139. Winston-Salem, North Carolina
  140. Bismarck, North Dakota
  141. Bismark, North Dakota
  142. Bismark, North Dakota
  143. Fargo, North Dakota
  144. Fargo, North Dakota
  145. Jamestown, North Dakota
  146. Minot, North Dakota
  147. Minot, North Dakota
  148. Oakes, North Dakota
  149. Akron, Ohio
  150. Akron, Ohio
  151. Centerville, Ohio
  152. Cincinnati, Ohio
  153. Cincinnati, Ohio
  154. Cleveland, Ohio
  155. Kettering, Ohio
  156. Lyndhurst, Ohio
  157. Mayfield Village, Ohio
  158. Oklahoma City, Oklahoma
  159. Oklahoma City, Oklahoma
  160. Oklahoma, Oklahoma
  161. Oklahoma, Oklahoma
  162. Tulsa, Oklahoma
  163. Yukon, Oklahoma
  164. Altoona, Pennsylvania
  165. Camp Hill, Pennsylvania
  166. Duncansville, Pennsylvania
  167. Johnstown, Pennsylvania
  168. Langhome, Pennsylvania
  169. Lemoyne, Pennsylvania
  170. Newtown, Pennsylvania
  171. Sellersville, Pennsylvania
  172. West Reading, Pennsylvania
  173. Wyomissing, Pennsylvania
  174. Anderson, South Carolina
  175. Belton, South Carolina
  176. Mt. Pleasant, South Carolina
  177. Aberdeen, South Dakota
  178. Sioux Falls, South Dakota
  179. Waterdown, South Dakota
  180. Watertown, South Dakota
  181. Memphis, Tennessee
  182. Memphis, Tennessee
  183. Memphis, Tennessee
  184. Memphis, Tennessee
  185. Nashville, Tennessee
  186. Bellaire, Texas
  187. Dallas, Texas
  188. Dallas, Texas
  189. Dallas, Texas
  190. Dallas, Texas
  191. Houston, Texas
  192. San Antonio, Texas
  193. San Antonio, Texas
  194. San Antonio, Texas
  195. Temple, Texas
  196. Waco, Texas
  197. Salt Lake City, Utah
  198. Norfolk, Virginia
  199. Virginia Beach, Virginia
  200. Seattle, Washington
  201. Seattle, Washington
  202. Seattle, Washington
  203. Seattle, Washington
  204. Spokane, Washington
  205. Milwaukee, Wisconsin
  206. Milwaukee, Wisconsin
  207. Cheyenne, Wyoming
  208. Provincia de Buenos Aires,
  209. Concord, New South Wales
  210. St Leonards, New South Wales
  211. Nedlands, Western Australia
  212. Herston,
  213. Keswick,
  214. Graz,
  215. Diepenbeek,
  216. Genk,
  217. Gent,
  218. Leuven,
  219. Liege,
  220. Schiepsebos,
  221. Goiania, GO
  222. Duque de Caxias - Cuiaba, MT
  223. Rio de Janeiro, RJ
  224. Rio de Janeiro, RJ
  225. Sorocaba, Sao Paulo
  226. São Paulo, SP
  227. Pleven,
  228. Plovdiv,
  229. Sofia,
  230. Sofia,
  231. Sofia,
  232. Sofia,
  233. Sofia,
  234. Calgary, Alberta
  235. Vancouver, British Columbia
  236. Vancouver, British Columbia
  237. Winnipeg, Manitoba
  238. Hamilton, Ontario
  239. Hawkesbury, Ontario
  240. Hawkesbury, Ontario
  241. London, Ontario
  242. Toronto, Ontario
  243. Toronto, Ontario
  244. Toronto, Ontario
  245. Toronto, Ontario
  246. Gatineau, Quebec
  247. Montreal, Quebec
  248. Montreal, Quebec
  249. Pointe-Claire, Quebec
  250. Sherbrooke, Quebec
  251. Trois-Rivieres, Quebec
  252. Saskatoon, Saskatchewan
  253. Saskatoon, Saskatchewan
  254. Quebec,
  255. Quebec,
  256. Santiago,
  257. Zadar,
  258. Zagreb,
  259. Aalborg,
  260. Ballerup,
  261. Vejle,
  262. Tallinn,
  263. Tartu,
  264. Tartu,
  265. Tartu,
  266. Jyvaskyla, FIN
  267. Jyvaskyla,
  268. Jyväskylä,
  269. Kuopio,
  270. Kuopio,
  271. Kuopio,
  272. Lahti,
  273. Oulu,
  274. Turku,
  275. Lyon Cedex 03,
  276. Orleans cedex 1,
  277. Paris,
  278. Berlin,
  279. Muenchen,
  280. Zerbst,
  281. Athens,
  282. Hong Kong,
  283. PRC,
  284. Sai Ying Pung,
  285. Bekescsaba,
  286. H-6720 Szeged,
  287. Kecskemet,
  288. Mako,
  289. Roma,
  290. Roma,
  291. Roma,
  292. Siena,
  293. Kaunas,
  294. Vilnius,
  295. Vilnius,
  296. seccion de Lomas Verdes, Estado de Mexico
  297. Mexico City,
  298. Mexico D.F.,
  299. Emmen, Dr
  300. Nijmegen, GA
  301. Amsterdam, HV
  302. Nijmegen, SZ
  303. Eindhoven,
  304. Rotterdam,
  305. Milford, Auckland
  306. Christchurch, NZ
  307. Auckland,
  308. Dunedin,
  309. Bergen,
  310. Hamar,
  311. Oslo,
  312. Oslo,
  313. Trondheim,
  314. Trondheim,
  315. Katowice,
  316. Krakow,
  317. Krakow,
  318. Krakow,
  319. Krakow,
  320. Krakow,
  321. Lublin,
  322. Warszawa,
  323. Warszawa,
  324. Warszawa,
  325. Warszawa,
  326. Warszawa,
  327. Warszawa,
  328. Warszawa,
  329. Warszawa,
  330. Warszawa,
  331. Wroclaw,
  332. Cluj-, Napoca
  333. Bucharesti,
  334. Bucharest,
  335. Bucuresti,
  336. Bucuresti,
  337. Cluj-Napoca,
  338. Iasi,
  339. Moscow,
  340. Moscow,
  341. Moscow,
  342. Moscow,
  343. Moscow,
  344. Moscow,
  345. Moscow,
  346. Moscow,
  347. Saint Petersburg,
  348. St Petersburg,
  349. St. Petersburg,
  350. St. Petersburg,
  351. St. Petersburg,
  352. Piestany, Slovak Republic
  353. Bratislava,
  354. Bratislava,
  355. Bratislava,
  356. Bratislava,
  357. Groenkloof, 0181, Pretoria
  358. Bedford Gardens,
  359. Johannesburg 2193,
  360. Johannesburg, 2193,
  361. Johannesburg,
  362. Johannesburg,
  363. Parow 7500,
  364. Parow,
  365. Pretoria, 0042,
  366. Pretoria, 0181,
  367. Pretoria,
  368. Pretoria,
  369. Somerset West, 7129,
  370. Somerset West, 7130,
  371. Somerset West,
  372. Stellenbosch 7600,
  373. Madrid,
  374. Madrid,
  375. Madrid,
  376. Madrid,
Female
55 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women
Official Title  ICMJE A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis
Brief Summary The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.
Detailed Description

Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women.

Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Osteoporosis
Intervention  ICMJE Drug: Bazedoxifene Acetate (TSE-424)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2009)		1742
Original Enrollment  ICMJE
 (submitted: May 30, 2007)		1735
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.
  • Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

Exclusion Criteria:

  • One (1) or more osteoporotic vertebral fractures (T4-L4).
  • Diseases that may affect bone metabolism.
  • Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00481169
Other Study ID Numbers  ICMJE 3068A1-300
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP