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A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)
Phase 4 trial testing alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus) in Osteoporosis, Postmenopausal in 219 participants. Completed in 10 January 2013.
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 219 |
| Start date | 19 June 2011 |
| Primary completion | 10 January 2013 |
| Estimated completion | 10 January 2013 |
Organon and Co — full company profile →
56 and older, female only, with Osteoporosis, Postmenopausal. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.
| Group | Value | 95% CI |
|---|---|---|
| Fosamax Plus | 3.54 | 2.7 – 4.4 |
| Calcitriol | 1.59 | 0.8 – 2.4 |
BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
| Group | Value | 95% CI |
|---|---|---|
| Fosamax Plus | 5.17 | 4.3 – 6.0 |
| Calcitriol | 2.26 | 1.4 – 3.1 |
s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 6.
| Group | Value | 95% CI |
|---|---|---|
| Fosamax Plus | -59.12 | -62.03 – -55.98 |
| Calcitriol | -16.75 | -22.53 – -10.54 |
s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 6.
| Group | Value | 95% CI |
|---|---|---|
| Fosamax Plus | -79.23 | -81.40 – -76.81 |
| Calcitriol | -27.20 | -34.58 – -18.99 |
s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 12.
| Group | Value | 95% CI |
|---|---|---|
| Fosamax Plus | -68.07 | -70.77 – -65.11 |
| Calcitriol | -17.00 | -23.79 – -9.60 |
s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 12.
| Group | Value | 95% CI |
|---|---|---|
| Fosamax Plus | -76.15 | -78.56 – -73.47 |
| Calcitriol | -24.19 | -31.58 – -16.00 |
The term "vitamin D insufficiency" is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture. In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D \<20 ng/mL.
| Group | Value | 95% CI |
|---|---|---|
| Fosamax Plus | 4.1 | |
| Calcitriol | 47.1 |
Time frame: Up to Month 12. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Fosamax Plus | Calcitriol |
|---|---|---|---|
| Femoral neck fracture | Injury, poisoning and procedural complications | — | — |
| Appendicitis | Infections and infestations | — | — |
| Cellulitis | Infections and infestations | — | — |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | — | — |
| Spinal compression fracture | Injury, poisoning and procedural complications | — | — |
| Patella fracture | Injury, poisoning and procedural complications | — | — |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | — | — |
| Cerebral infarction | Nervous system disorders | — | — |
| Vertebrobasilar insufficiency | Nervous system disorders | — | — |
| Reaction | System | Fosamax Plus | Calcitriol |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — |
| Urine calcium increased | Investigations | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Vitamin D deficiency | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Femoral neck fracture, Appendicitis, Cellulitis, Lumbar vertebral fracture, Spinal compression fracture, Patella fracture, Spondylolisthesis, Cerebral infarction.
Data from ClinicalTrials.gov NCT01350934 adverse events section.
This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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