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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Randomized trial of alendronate plus vitamin D
3
versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency
Calcified Tissue International, Volume 88, No. 6, Year 2011
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Description
Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D3 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score ≤2.5 or ≤1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70% of cases this was combined with vitamin D supplements. However, only 24% took ≥800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6% in the ALN/D5600 group compared with 31.0% in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57% vs. -46%, P < 0.001) and bone-specific alkaline phosphatase (-47% vs. -40%, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9% vs. 3.9%, P = 0.047) and the total hip (2.2% vs. 1.4%, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3% vs. 36.9%, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women. © 2011 Springer Science+Business Media, LLC.
Authors & Co-Authors
Ralston, Stuart H.
Unknown Affiliation
Binkley, N.
Unknown Affiliation
Boonen, Steven
Unknown Affiliation
Kiel, Douglas P.
Unknown Affiliation
Reginster, Jean Yves
Unknown Affiliation
Roux, Christian Hubert
Unknown Affiliation
Chen, Liang
Unknown Affiliation
Rosenberg, Elizabeth
Unknown Affiliation
Santora, A.
Unknown Affiliation
Coughlan, Tara L.
Unknown Affiliation
Arabi, Asma
Unknown Affiliation
Kucukdeveci, Ayse
Unknown Affiliation
Savani, Naren
Unknown Affiliation
Kausiene, Rasa
Unknown Affiliation
Pornel, Bruno
Unknown Affiliation
Price, Tom
Unknown Affiliation
Benhamou, C.
Unknown Affiliation
Aguilar, Maria
Unknown Affiliation
Abello, Mauricio
Unknown Affiliation
Tobias, Elgardo
Unknown Affiliation
Rais, Nadeem
Unknown Affiliation
Ershova, Olga B.
Unknown Affiliation
Martz, Rene
Unknown Affiliation
Linjawi, Sultan
Unknown Affiliation
Kramer, Stuart
Unknown Affiliation
Walliser, Jesus
Unknown Affiliation
Hepguler, Simin
Unknown Affiliation
Gimble, Jeffrey
Unknown Affiliation
Lesnyak, Olga
Unknown Affiliation
Chalem, Philippe
Unknown Affiliation
Aranburu Albizuri, José Miguel
Unknown Affiliation
Foldes, J.
Unknown Affiliation
Yaghi, Y.
Unknown Affiliation
Abud, Carlos
Unknown Affiliation
Muñoz Torres, Manuel
Unknown Affiliation
González, Gilberto
Unknown Affiliation
Weryha, Georges
Unknown Affiliation
Martín-Mola, Emilio
Unknown Affiliation
Shargordsky, Marina
Unknown Affiliation
Lippuner, Kurt
Unknown Affiliation
Moericke, Ruediger
Unknown Affiliation
Masri, Basel K.
Unknown Affiliation
Stura, Inguta
Unknown Affiliation
Theiler, Robert
Unknown Affiliation
Dursun, Nigar
Unknown Affiliation
Thompson, Vincent
Unknown Affiliation
Andersone, Dac
Unknown Affiliation
Arya, Mark
Unknown Affiliation
Anderberg, Carl Peter
Unknown Affiliation
Pfeifer, Michael
Unknown Affiliation
Goldstraj, Hugo
Unknown Affiliation
Alekna, Vidmantas
Unknown Affiliation
Wieskopf, Bram
Unknown Affiliation
de Villiers, Tobias J.
Unknown Affiliation
Minisola, Salvatore
Unknown Affiliation
Heil, Klaus
Unknown Affiliation
Herkt, Volkmar
Unknown Affiliation
Rohlf, Jane
Unknown Affiliation
De Weerd, Albert
Unknown Affiliation
Ish-Shalom, Sophia
Unknown Affiliation
Bukauskiene, Loreta
Unknown Affiliation
Benevolenskaya, Lidia
Unknown Affiliation
Mantilla, Ruben
Unknown Affiliation
Woolf, Anthony D.
Unknown Affiliation
Otero, William
Unknown Affiliation
Nayiager, Savithree
Unknown Affiliation
Walsh, James Bernard
Unknown Affiliation
Newman, Stephen
Unknown Affiliation
Bagul, Nitin
Unknown Affiliation
Abdulhakim, Essam Eldin Ahmed
Unknown Affiliation
Govindraj, Shilpa
Unknown Affiliation
Sarmiento, Rex
Unknown Affiliation
Ellahbadi, Rahul
Unknown Affiliation
Shaw, Hilary
Unknown Affiliation
Thomas, Hawys
Unknown Affiliation
Lipschitz, Stanley
Unknown Affiliation
Gutierrez, Sergio
Unknown Affiliation
Ralston, Stuart H.
Unknown Affiliation
Davey, Michael R.
Unknown Affiliation
Lauro, Renato
Unknown Affiliation
Rodriguez, Hector
Unknown Affiliation
Al-Ramahi, Muataz
Unknown Affiliation
Statistics
Citations: 82
Authors: 82
Affiliations: 80
Identifiers
Doi:
10.1007/s00223-011-9482-4
ISSN:
0171967X
e-ISSN:
14320827
Research Areas
Health System And Policy
Noncommunicable Diseases
Violence And Injury
Participants Gender
Female