Quality of life in Japanese women with postmenopausal osteoporosis treated with raloxifene and vitamin D: post hoc analysis of a postmarketing study

Ohta, Hiroaki; Hamaya, Etsuro; Taketsuna, Masanori; Sowa, Hideaki

doi:10.1185/03007995.2014.975339

Cited by 3 publications

(6 citation statements)

References 50 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Raloxifene alone for 6 or 12 months was shown to improve EQ-5D in Japanese and European women 12 , 13 . Our results are consistent with a previous study demonstrating that 6-month combination therapy with raloxifene and alfacalcidol significantly improved QOL assessed using EQ-5D compared with baseline or raloxifene alone in 506 Japanese postmenopausal women with osteoporosis 11 .…”

Section: Discussionsupporting

confidence: 92%

“…Thus, a combination treatment containing SERM and vitamin D is expected to improve compliance and convenience as well as the effectiveness of osteoporosis treatment. In addition, beyond bone density and fracture, improvement in quality of life (QOL) is an important outcome in the treatment of osteoporosis 11 . Several studies have investigated the effects of anti-osteoporotic medications such as raloxifene or vitamin D alone on QOL 12 – 14 , but the effects of SERM and vitamin D combination therapy on QOL have not been fully evaluated 11 .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Quality of life and patient satisfaction with raloxifene/cholecalciferol combination therapy in postmenopausal women

Lee

Chung

2022

Sci Rep

View full text Add to dashboard Cite

This study was performed to evaluate quality of life (QOL) and patient satisfaction with raloxifene/cholecalciferol combination therapy in postmenopausal women with low bone mass. This multicenter, prospective, noninterventional observational study included 3907 postmenopausal women who received a combination of raloxifene 60 mg and cholecalciferol 800 IU daily to treat or prevent osteoporosis. Changes in QOL and patient satisfaction were evaluated after 3 and 6 months of treatment. In addition, the safety profile was assessed. Mean age was 67.7 ± 9.3 years old. QOL, assessed by European Quality of life instrument 5 Dimensions (EQ-5D) index, improved significantly after 3 months (0.81 ± 0.11, P < 0.001) and 6 months (0.82 ± 0.11, P < 0.001) of treatment compared to the baseline (0.78 ± 0.14). Improvement in QOL was also significant regardless of previous regimens both in women who were switched from other drugs (bisphosphonates or selective estrogen receptor modulators) and in women who received the study drug for the first time (P < 0.001 for all comparisons). Percentage of women satisfied with the effects (from 37.3 to 67.7%, P < 0.001) and convenience (from 42.8 to 74.1%, P < 0.001) of treatment compared to previous medication significantly increased after 6 months of treatment. In addition, serious adverse drug reactions did not occur, and hot flushes were observed only in 12 women (0.3%). Combination therapy with raloxifene and cholecalciferol significantly improves quality of life with no serious adverse events and high patient satisfaction at 6 months. Our real-world data suggest that this regimen is a promising option for postmenopausal women with low bone mass.

show abstract

Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Quality of life and patient satisfaction with raloxifene/cholecalciferol combination therapy in postmenopausal women

Lee

Chung

2022

Sci Rep

View full text Add to dashboard Cite

show abstract

“…30 For this reason, RLX is often prescribed in combination with vitamin D. Post hoc analysis of the combination of RLX and vitamin D in Japan demonstrated sufficient drug safety in patients aged ≥75 years with osteoporosis. 20 Also, the combination treatment of RLX and vitamin D was compared with no medication (no RLX group), similar to the actual clinical situation. The results of this study consistently demonstrated that the combination of RLX and vitamin D prevented a decrease in the local BMD and improved rotator cuff tendon-to-bone healing in a rat model.…”

Section: Discussionmentioning

confidence: 99%

“…2,11 Raloxifene (RLX) is one of these SERMs, and a combination of RLX and vitamin D is widely used in postmenopausal women. 7,20,24 Few studies, however, have reported on the interaction between estrogen and the rotator cuff enthesis. Recently, an estrogen-deficient state in rats that have undergone ovariectomy (OVX) has been shown to worsen the biomechanical properties of bone-to-tendon healing and inhibit chondroid tissue formation in repair tissue.…”

mentioning

confidence: 99%

A Combination Treatment of Raloxifene and Vitamin D Enhances Bone-to-Tendon Healing of the Rotator Cuff in a Rat Model

et al. 2020

View full text Add to dashboard Cite

Background: Tearing and degeneration of the rotator cuff at the tendon-to-bone junction are common in adults aged ≥50 years. Few studies have reported on the relationship between estrogen and the rotator cuff enthesis. In addition to preventing bone loss, selective estrogen receptor modulators have been shown to improve tendon and muscle quality. Purpose: To evaluate the effects of raloxifene (RLX) and vitamin D on rotator cuff tendon-to-bone healing in a rat model. Study Design: Controlled laboratory study. Methods: A total of 29 female rats (58 shoulders) were assigned to 4 groups: (1) control group, (2) ovariectomy (OVX)–only group, (3) no RLX group (OVX and rotator cuff repair [RCR]), and (4) RLX group (OVX, RCR, and RLX). Rats that did not undergo rotator cuff tear (RCT) surgery were divided into the control and OVX-only groups according to OVX surgery. Rats that underwent RCT surgery and RCR were divided into the no RLX and RLX groups according to RLX and vitamin D administration. An estrogen-deficient state was induced by OVX at 12 weeks of age. Bone mineral density (BMD) and trabecular bone characteristics were measured by micro–computed tomography, and healing of the tendon-to-bone junction was evaluated by biomechanical testing, histomorphometry, and micro–magnetic resonance imaging (MRI). Results: The mean final body weight (BW; 461.6 ± 47.3 g) of the OVX-only group was significantly higher and BMD (0.25 ± 0.07 g/cm3) was significantly lower ( P < .001) than the mean final BW (338.5 ± 35.1 g) and BMD (0.48 ± 0.05 g/cm3) of the control group. In contrast, the RLX group showed that the BW (369.6 ± 35.8 g) and BMD (0.41 ± 0.08 g/cm3) were not significantly different from the control group. The RLX group had a significantly higher histomorphometric total score (8.50 ± 1.05) than the no RLX group (4.83 ± 2.48). On biomechanical testing, the RLX group (29.7 ± 9.1 N) showed a significantly higher load to failure than the no RLX group (19.4 ± 8.8 N). On micro-MRI, the RLX group had a more homogeneous low signal and tendon continuity than the no RLX group. Conclusion: The combination treatment of RLX and vitamin D prevented a decrease in local BMD (greater tuberosity of the proximal humerus) and enhanced tendon-to-bone healing of the rotator cuff in a rat model. Clinical Relevance: This study induced an estrogen-deficient state similar to the human postmenopausal state and used drugs that are actually being prescribed in a clinical situation.

show abstract

“…The therapeutic response of raloxifene varies widely among patients; a few cases of osteonecrosis of the jaw have been reported (Bindakhil et al, 2021). With raloxifene, prospective (Scharla et al, 2006) and post hoc (Ohta et al, 2015) studies showed an improvement of pain. In a RCT (Fujita et al, 2010), back and knee pain were improved with raloxifene, when measured by VRS (p = 0.0017) and electroalgometry (p = 0.0045).…”

Section: Sermsmentioning

confidence: 95%

Osteoporosis treatment and pain relief: A scoping review

Pickering¹,

Javier

Malochet³

et al. 2023

European Journal of Pain

View full text Add to dashboard Cite

Background and ObjectiveAnti‐osteoporosis (OP) drugs have been suggested to contribute to pain reduction during OP management. This scoping review aimed at mapping the literature on pain relief with anti‐OP drugs in OP treatment.Databases and Data TreatmentMedline, Pubmed and Cochrane databases were searched by two reviewers with keywords combinations. Randomized controlled and real‐life English studies, pain as an endpoint, antiosteoporosis drugs were inclusion criteria. Case reports, surveys, comment letters, conference abstracts, animal studies and grey literature were excluded. Predetermined data were extracted by two reviewers and disagreement solved through discussion.ResultsA total of 130 articles were identified, 31 publications were included, 12 randomized clinical trials and 19 observational studies. Pain reduction was assessed by different tools: Visual Analogue Scale, Verbal Rating Scale, Facial Scale or as a domain of quality of life questionnaires including Short form 8, 36, mini‐OP, Japanese OP, Qualeffo, Roland Morris Disability questionnaires. Collective data show that anti‐OP drugs may display an analgesic effect that may be linked to the local mode of action of drugs on bone and consecutive modulation of pain sensitization. The methodology of the studies showed a heterogeneity of endpoints, comparators, statistical approaches and follow‐up duration.ConclusionConsidering the limitations of the literature, there is a need for more rigorous trials and larger real‐life studies taking into account the recommendations published for research in rheumatology and in pain medicine. The identification of responders, patient subtypes, and of analgesic‐effect doses would allow optimization and individualization for pain relief in patients with OP.Significance StatementThis scoping review shows that anti‐OP drugs may improve pain and quality of life of patients with OP. The heterogeneity in design, choice of endpoints, methodology, comparators and follow‐up duration of included randomized clinical trials and real‐life studies does not allow so far to identify a predominant antiosteoporosis drug or an optimal dosage for pain relief. These gaps need to be addressed and warrant further research in the future for optimizing pain improvement in the course of OP drug treatment.

show abstract

Quality of life in Japanese women with postmenopausal osteoporosis treated with raloxifene and vitamin D: post hoc analysis of a postmarketing study

Abstract: Active vitamin D3 supplementation to raloxifene treatment for 24 weeks may have additional benefits in improving QOL and relieving pain in Japanese women with postmenopausal osteoporosis.

Cited by 3 publications

References 50 publications

Quality of life and patient satisfaction with raloxifene/cholecalciferol combination therapy in postmenopausal women

Quality of life and patient satisfaction with raloxifene/cholecalciferol combination therapy in postmenopausal women

A Combination Treatment of Raloxifene and Vitamin D Enhances Bone-to-Tendon Healing of the Rotator Cuff in a Rat Model

Osteoporosis treatment and pain relief: A scoping review

Contact Info

Product

Resources

About